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T Cell Depletion

Stem Cell Transplantation for Leukemia

Phase 2

Waitlist Available

Led By Marie Bleakley

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

Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation and have specific diagnoses including acute lymphocytic leukemia, acute myeloid leukemia, refractory anemia with excess blasts, chronic myelogenous leukemia, and other acute leukemia or related neoplasm

HLA-matched related donors >= 18 years and capable and willing to donate PBSC

Must not have

Patients with specific medical conditions such as CNS involvement refractory to treatment, uncontrolled infections, organ dysfunction, HIV positivity, and certain weight restrictions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for cancer patients who need a peripheral blood stem cell transplant. The study is testing how well a selective removal of naïve T cells works in preventing GVHD after the transplant.

Who is the study for?

This trial is for patients aged 0-60 with acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome or chronic myeloid leukemia who are suitable for stem cell transplantation. They must have a matched donor and acceptable organ function. Exclusions include uncontrolled infections, severe heart/lung/kidney disease, previous certain transplants, pregnancy/breastfeeding without contraception use, other significant medical conditions or participation in conflicting trials.

What is being tested?

The trial tests whether selectively removing naïve T cells from donor stem cells before transplant can prevent Graft-Versus-Host-Disease (GVHD) while preserving the benefits of fighting infections and killing residual leukemia cells. It involves high/medium intensity chemo/radiotherapy followed by infusion of modified donor blood stem cells.

What are the potential side effects?

Potential side effects may include reactions to immune suppression drugs like tacrolimus and methotrexate such as increased infection risk, liver dysfunction, kidney damage; complications from chemotherapy and radiotherapy like fatigue, nausea; plus risks associated with stem cell transplantation including GVHD.

Eligibility Criteria

Inclusion Criteria

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

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I am a candidate for a stem cell transplant and have a specific type of blood cancer.

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My donor is 18 or older, matches my HLA, and agrees to donate stem cells.

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I have a donor match willing to donate stem cells.

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I have a donor who matches my HLA type for a stem cell donation.

Exclusion Criteria

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

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I do not have uncontrolled infections, severe organ problems, HIV, or fall outside the weight limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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

Occurrence of chronic graft-versus-host disease (GHVD), defined operationally as the occurrence of compatible symptoms meeting National Institutes of Health criteria and requiring systemic pharmacological immunosuppression

Presence of acute graft-versus-host disease (GVHD) grades II-IV

Secondary study objectives

Chimerism analysis

Relapse

Transplant related mortality

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478

23%

Blood/Bone marrow

11%

Cardiovascular

Pulmonary

Gastrointestinal

Hepatic

Graft versus host disease with infection and organ failure

Dermatology/Skin

respiratory failure

Hemorrhage

subdural hematoma

thrombosis

Renal/Genitourinary

Metabolic/Laboratory

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (TBI, Transplant, GVHD Prophylaxis)

Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D (MUD)Experimental Treatment8 Interventions

LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.

Group II: Arm C (MUD)Experimental Treatment9 Interventions

HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Group III: Arm B (MRD)Experimental Treatment9 Interventions

LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.

Group IV: Arm A (MRD)Experimental Treatment9 Interventions

HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Total-Body Irradiation

1997

Completed Phase 3

~1180

Mycophenolate Mofetil

1997

Completed Phase 4

~2380