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Alkylating agents

Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer

Phase 1 & 2

Waitlist Available

Led By Brenda Sandmaier

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant, that may be less toxic, is able to treat underlying blood cancer. Stem cells are "seed cells" necessary to make blood cells. Researchers want to see if using less radiation and less chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work. Researchers are hoping to see a mixture of recipient and donor stem cells after transplant. This mixture of donor and recipient stem cells is called "mixed-chimerism". Researchers hope to see these donor cells eliminate tumor cells. This is called a "graft-versus-leukemia" response.

Eligible Conditions

Remission
Renal Cell Carcinoma
Childhood Cancer
Anemia
Leukemia
Childhood Leukemia
Renal Medullary Carcinoma
Kidney Cancer
Acute Lymphoblastic Leukemia
Lymphoma
Sideroblastic Anemia
Non-Hodgkin's Lymphoma
Chronic Myelomonocytic Leukemia
Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Myelodysplastic Syndrome
Cancer
Acute Myeloid Leukemia
Multiple Myeloma
Myelodysplastic Syndromes (MDS)
Adult Hodgkin's Lymphoma

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

Risk of grades II-IV acute GVHD in those patients with sustained engraftment

Risk of true graft rejection in patients with and without preceding chemotherapy

Secondary study objectives

Incidence of reversing impending graft rejection (less than 40% donor cluster of differentiation [CD]3+ T cell chimerism)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (PBSCT)Experimental Treatment6 Interventions

REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -4, -3, and -2 and undergo TBI on day 0. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO every 8 hours on days 0-40 with taper to day 96.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Total-Body Irradiation

1997

Completed Phase 3

~1180

Cyclosporine

FDA approved

Peripheral Blood Stem Cell Transplantation

1997