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Anti-metabolites

Stem Cell Transplant for Blood Cancers

Phase 2

Recruiting

Led By Filippo Milano

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

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

Must have

Large cell lymphoma in > second CR (CR2)/ >= PR2

Myelodysplastic syndromes (MDS)

Must not have

Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiation of conditioning (day -6)

Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a donor stem cell transplant with chemotherapy and radiation to see if it can treat blood cancers.

Who is the study for?

This trial is for patients with various blood cancers who have responded poorly to other treatments or are in remission. They must be over 6 months old, have good heart and lung function, normal liver enzymes, acceptable kidney function, and a Karnofsky/Lansky score indicating they can carry out daily activities. Pregnant women and those with uncontrolled infections or hypersensitivity to the drugs used in the trial cannot participate.

What is being tested?

The study tests if chemotherapy (treosulfan and fludarabine), total-body irradiation, followed by donor stem cell transplant is effective for treating blood cancers. The treatment aims to destroy cancer cells and make space for new stem cells from a donor that match the patient's immune system.

What are the potential side effects?

Potential side effects include reactions related to immune suppression such as infection risk increase; organ damage due to intense chemotherapy; complications from radiation exposure; graft-versus-host disease where donated cells attack the body; nausea; fatigue; hair loss.

Eligibility Criteria

Inclusion Criteria

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

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My large cell lymphoma is in its second or later remission.

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I have been diagnosed with myelodysplastic syndromes.

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My Hodgkin Lymphoma is in its third or later remission.

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My low grade lymphoma has worsened after two treatments but is now in partial or complete remission.

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My kidney function is within the required range.

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My high-grade lymphoma is responding to treatment.

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My CML is in the first phase and didn’t respond well to a specific cancer drug.

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I have been diagnosed with chronic myelomonocytic leukemia.

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My child can do most activities but may need help.

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My acute leukemia is in remission, with or without minimal signs of disease.

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My lungs are working well.

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I am a relative of the patient, 12 or older, weigh at least 40 Kg, and meet specific health criteria.

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I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

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

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My leukemia in the brain didn't respond to initial treatments.

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I have another cancer with a survival rate less than 75% in 5 years.

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My DSA levels are below 5000 after treatment.

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I do not have any severe infections that are currently untreated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-transplant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Graft failure/rejection

Secondary study objectives

Acute graft versus host disease

Chronic graft versus host disease

Clinically significant infections

+3 more

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: Arm B (low dose treosulfan)Experimental Treatment15 Interventions

Patients receive low dose treosulfan IV over 120 minutes on days -6 to -4 and fludarabine IV over 60 minutes on days -6 to -2. Patients then undergo total-body irradiation and allogeneic hematopoietic stem cell transplantation, and receive cyclophosphamide, cyclosporine, mycophenolate sodium or mycophenolate mofetil, and filgrastim as in Arm A. Additionally, patients undergo bone marrow aspiration and biopsy, and echocardiography at baseline and blood sample collection and CT or PET/CT on study.

Group II: Arm A (high dose treosulfan)Experimental Treatment15 Interventions

Patients receive high dose treosulfan IV over 120 minutes on days -6 to -4 and fludarabine IV over 60 minutes on days -6 to -2. Patients then undergo total-body irradiation on day -1 and allogeneic hematopoietic stem cell transplantation on day 0. Patients then receive cyclophosphamide IV over 1-2 hours on days 3-4. Beginning on day 5, patients receive cyclosporine IV BID or TID over 1-2 hours or PO (after 3 months, in the absence of GVHD, cyclosporine tapering will start by 5-10% per week, until drug withdrawal at 6 months post-transplant). Beginning on day 5, patients also receive mycophenolate sodium PO TID or mycophenolate mofetil IV or PO TID until day 35 (may be continued if active GVHD is present). Beginning on day 5, patients also receive filgrastim until the absolute neutrophil count is \> 1,000/uL for 3 consecutive days. Additionally, patients undergo bone marrow aspiration and biopsy, and echocardiography at baseline and blood sample collection and CT or PET/CT on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Positron Emission Tomography

2011

Completed Phase 2

~2200