Advertisement

Topics

Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)

2014-08-27 03:12:17 | BioPortfolio

Summary

The goal of Part 1 of this clinical research study is to learn about the safety of the combination of plerixafor and clofarabine when given to patients with previously untreated AML who are at least 60 years old.

The goal of Part 2 of this study is to learn if the combination of plerixafor and clofarabine can help to control previously untreated AML in patients who are at least 60 years old.

Description

The Study Drugs:

Plerixafor is designed to block a protein on cancer cells from attaching to cells in the bone marrow. This may allow cells in the bone marrow to be more effectively treated by chemotherapy.

Clofarabine is designed to interfere with the growth and development of cancer cells.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 3 groups of up to 6 participants will be enrolled in the Part 1 portion of the study, and up to 48 participants will be enrolled in Part 2.

If you are enrolled in Part 1, the dose of plerixafor you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of plerixafor. Each new group will receive a higher dose of plerixafor than the group before it, if no intolerable side effects were seen.

If you are enrolled in Part 2, you will receive plerixafor at the highest dose that was tolerated in Part 1.

All participants will receive the same doses of clofarabine.

Study Drug Administration:

Cycles in this study are 28 days long, or possibly longer depending on your blood counts, any side effects, and the status of the disease.

On Days 1-5 of each cycle, you will receive plerixafor through a needle under the skin of your abdomen.

On Days 1-5 of each cycle, you will receive clofarabine by vein over about 1 hour. The dose will begin about 4 to 6 hours after the plerixafor injection. You will be watched for side effects while you receive clofarabine.

If the doctor thinks it is in your best interest, the dose level of plerixafor may be lowered.

Cycle 1 is called Induction. If the disease goes into remission (responds well) after the Induction cycle, you will start the Consolidation part of the study. In the Consolidation cycles, the schedule of administration of the drugs will be the same as in the Induction cycle, but the doses of clofarabine will be lower. If the disease does not go into remission after the Induction cycle, you will have a Reinduction cycle before you can begin the Consolidation part of the study. The goal of the Induction cycle and possible Reinduction cycle is to affect the bone marrow a certain way that may help control the disease. The goal of Consolidation is also to help control the disease.

During Cycle 1, you will stay in an area of the hospital called the Protective Environment (PE) unit. It is designed to be as clean as possible to lower the risk of infections. Most likely, you will stay in a PE hospital room for the entire time during Cycle 1. Your doctor will discuss this with you. Your family members and visitors will not be allowed to go into your PE room, but there are family/visitor rooms that are separated from you by glass windows.

Study Visits:

Induction (Cycle 1):

On Day 1 of Induction, blood (about ½ tablespoon each time) will be drawn for routine tests before the plerixafor injection and 3 times during the 9 hours after the injection.

On Days 2-5 of Induction, blood (about ½ tablespoon each time) will be drawn for routine tests before the plerixafor injection and again at 8 hours (+/- 1 hour) after the injection.

Starting in Week 2 of Induction, blood (about 2 tablespoons) will be drawn at least 2 times a week for routine tests.

You will have a bone marrow aspiration and/or biopsy to check the status of the disease on Day 21 of Induction (+/- 7 days) and every 2 weeks (+/- 7 days) after that, until the Induction cycle is over.

Reinduction:

If you have a Reinduction cycle, blood (about 2 tablespoons) will be drawn at least 2 times a week during Reinduction for routine tests. You will have a bone marrow aspiration and/or biopsy to check the status of the disease on Day 21 of Reinduction (+/- 7 days) and every 2 weeks (+/- 7 days) after that, until the Reinduction cycle is over.

Consolidation:

Blood (about 2 tablespoons) will be drawn 1 time a day for routine tests on Days 1-5 of Consolidation.

Starting in Week 2 of each Consolidation cycle, blood (about 2 tablespoons) will be drawn for routine tests every week for the rest of each Consolidation cycle.

You will have a bone marrow aspiration and/or biopsy to check the status of the disease anytime during Consolidation that the doctor decides it is needed.

Induction, Reinduction, and Consolidation:

The blood tests and/or bone marrow aspirations/biopsies may be performed more often than listed if the doctor thinks it is needed. Also, you will have an ECG anytime during the study if the doctor thinks it is needed.

Length of Study:

You may continue taking the study drugs for up to 5 Consolidation cycles, if the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.

Your participation on the study will be over once you have completed the follow-up visits.

Follow-Up Visits:

At 1 and 3 months (+/- 7 days) after you stop taking the study drugs:

- Blood (about 2 tablespoon) will be drawn for routine tests.

- If the doctor decides it is needed, you will have a bone marrow aspiration to check the status of the disease.

If the disease responds (if it goes into complete or partial remission), you will have follow-up visits every 3 months for up to 2 years after you stop taking the study drugs. The follow-up visits will stop if the disease gets worse, or if you start a new cancer therapy and the disease has not gotten worse. The following tests and procedures will be performed at the follow-up visits:

- Blood (about 2 tablespoon) will be drawn for routine tests.

- If the doctor decides it is needed, you will have a bone marrow aspiration to check the status of the disease.

This is an investigational study. Clofarabine is FDA approved and commercially available to treat acute lymphoblastic leukemia (ALL) in children after the disease has gotten worse a second time. Plerixafor is FDA approved to be given with G-CSF and is commercially available for use in moving stem cells into the bloodstream before a stem cell transplant to treat non-Hodgkin's lymphoma or multiple myeloma. The combination of clofarabine and plerixafor is investigational.

Up to 66 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myelogenous Leukemia

Intervention

Plerixafor, Clofarabine

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:17-0400

Clinical Trials [2173 Associated Clinical Trials listed on BioPortfolio]

Investigation of Clofarabine in Acute Leukemias

The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphoc...

Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who...

A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (A...

A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who...

T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer figh...

PubMed Articles [6507 Associated PubMed Articles listed on BioPortfolio]

A phase 1 study of chemosensitization with plerixafor plus G-CSF in adults with relapsed acute myeloid leukemia.

Importance of Acute Lymphoblastic Leukemia-type Therapy for Bilineal Acute Leukemia.

We examined 3 pediatric patients with bilineal acute leukemia. Patient 1 with B-cell acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) with B-ALL dominance responded well to pred...

ZNF224 is a transcriptional repressor of AXL in chronic myeloid leukemia cells.

ZNF224 is a KRAB-zinc finger transcription factor that exerts a key tumor suppressive role in chronic myelogenous leukemia. In this study, we identify the receptor tyrosine kinase Axl as a novel targe...

Mixed phenotype (T/B/myeloid) extramedullary blast crisis as an initial presentation of chronic myelogenous leukemia.

Chronic myelogenous leukemia (CML) is a myeloproliferative disorder characterized by the Philadelphia (Ph) chromosome generated by the reciprocal translocation t(9,22)(q34;q11). The natural progressio...

Concurrent Acute Myelofibrosis and Acute Lymphoblastic Leukemia in Childhood: Case Report and Review of the Literature.

Myelofibrosis is associated with a wide variety of neoplastic and non-neoplastic bone marrow diseases, predominately myeloproliferative neoplasms and acute myeloid leukemia. The following case documen...

Medical and Biotech [MESH] Definitions

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

Conditions in which the abnormalities in the peripheral blood or bone marrow represent the early manifestations of acute leukemia, but in which the changes are not of sufficient magnitude or specificity to permit a diagnosis of acute leukemia by the usual clinical criteria.

An acute myeloid leukemia in which 80% or more of the leukemic cells are of monocytic lineage including monoblasts, promonocytes, and MONOCYTES.

More From BioPortfolio on "Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...


Searches Linking to this Trial