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Procedure

Shortened Chemotherapy Before Stem Cell Transplant for Blood Cancers

Phase 1

Waitlist Available

Led By Michael Scordo, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Acute myeloid leukemia (AML) with intermediate or high-risk features in CR1.

Patients aged ≥ 18 years old.

Must not have

Patients who have undergone previous autologous HCT within the last 6 months, with the exclusion of high-risk multiple myeloma patients.

Patients with active extramedullary disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in the first 30 days post-hct

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new, shorter chemotherapy regimen for people with blood cancers before a transplant. Researchers want to know if the new regimen has the same or fewer side effects as the current one.

Who is the study for?

Adults with various blood cancers eligible for stem cell transplantation may join this trial. They should have specific types of leukemia, myeloma, or lymphoma responding to therapy, adequate organ function, and not be pregnant or breastfeeding. Those with active brain cancer, uncontrolled infections, recent autologous transplants (except certain myeloma cases), HIV/HTLV, or unwillingness to use contraception are excluded.

What is being tested?

The study is testing a shortened chemotherapy regimen before allogeneic hematopoietic cell transplantation (Allo-HCT). It involves lower doses of busulfan combined with melphalan and fludarabine plus antithymocyte globulin (ATG) to see if it reduces severe side effects within 30 days post-transplant.

What are the potential side effects?

Potential side effects include reactions related to ATG such as fever and chills; chemotherapy-related nausea, vomiting; low blood counts leading to infection risk; liver dysfunction from busulfan; heart issues from melphalan; and general fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My AML is in the first complete remission and is not low risk.

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I am 18 years old or older.

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I am recommended for a stem cell transplant due to my blood cancer.

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My leukemia is in remission but at high risk of returning, or it's in its second or later remission.

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I have been diagnosed with severe aplastic anemia.

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My condition relapsed after my own stem cell transplant or I can't have this type of transplant.

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I have been diagnosed with chronic myelomonocytic leukemia.

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My tests show genetic changes that could lead to a severe type of leukemia.

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My condition worsened after a stem cell transplant or I can't have one.

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My multiple myeloma is high-risk or has relapsed after a stem cell transplant.

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My AML has returned after achieving a second complete remission.

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My condition is not a result of treatment for another cancer.

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My leukemia is in its first or later remission.

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My CML is in an advanced stage but has less than 10% blasts after treatment.

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I do not have life-threatening low blood cell counts.

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My CML is resistant to standard treatments due to a specific mutation.

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I can take care of myself and perform daily activities.

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I did not respond well or was intolerant to specific cancer medication.

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My non-Hodgkin lymphoma has come back after treatment.

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My Hodgkin lymphoma has returned after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant using my own cells less than 6 months ago, except if I have high-risk multiple myeloma.

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My cancer has spread outside the bone marrow.

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I have had a bone marrow transplant from a donor.

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I have an active brain or spinal cord tumor.

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I do not have any active or uncontrolled infections.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in the first 30 days post-hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in the first 30 days post-hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and in the first 30 days post-hct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

the number of grade 4 toxicities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: patients with multiple myelomaExperimental Treatment5 Interventions

A. Busulfan 0.8 mg/kg every 6 hours x 10 doses, with dose adjustments made according to PK levels. B. Melphalan (70 mg/m2/day) administered on days -6 and -5. C. Fludarabine (25 mg/m2/day) administered on days -6, -5, -4, -3, -2. All patients receiving matched related or unrelated donor allografts receive anti-thymocyte globulin (ATG) 2.5 mg/kg/day on days -3 and -2 to deplete chemotherapy resistant host T-cells that could hinder engraftment, and it may provide additional GVHD prophylaxis.

Group II: patients hematologic malignancies other than multiple myelomaExperimental Treatment5 Interventions

A. Busulfan 3.2 mg/kg/day, with dose adjustments made according to pharmacokinetic (PK) levels. B. Melphalan (70mg/m2/day) administered on days -6 and -5. C. Fludarabine (25mg/m2/ day) administered on days -6, -5, -4, -3, and -2. All patients receiving matched related or unrelated donor allografts receive anti-thymocyte globulin (ATG) 2.5 mg/kg/day on days -3 and -2 to deplete chemotherapy resistant host T-cells that could hinder engraftment, and it may provide additional GVHD prophylaxis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1830

Melphalan

2008

Completed Phase 3

~1500