Transplantation of Hematopoietic Stem Cells From HLA-compatible Donors in Patients With B-Cell Lymphoid Malignancies

Recruiting in Palo Alto (17 mi)

Overseen byGuenther Koehne, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Baptist Health South Florida

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research study is being conducted to treat patients with B-cell lymphoid malignancies. These types of cancers include diffuse large cell (DLBCL) non-Hodgkin's lymphoma (NHL), mantle cell NHL, any indolent B cell NHL (such as follicular, small cell or marginal zone NHL), or chronic lymphocytic leukemia (CLL). Patients with these types of lymphomas have been shown to benefit from peripheral blood stem cell transplantation (PBSCT). PBSCT uses healthy blood stem cells from a donor to replace your diseased or damaged bone marrow. Before undergoing PBSCT, you'll receive chemotherapy and/or radiation to destroy your diseased cells and prepare your body for the donor cells. This is called a "conditioning regimen." Non-myeloablative (NMA) conditioning causes minimal cell death. This research study will look at a course of treatment using NMA conditioning regimen including low dose chemotherapy and low dose radiation as well as rituximab and PBSCT from a compatible donor. The primary aim is to obtain a preliminary estimate of the overall and event-free survival 1 year post-transplant after NMA.

Research Team

Guenther Koehne, MD, PhD

Principal Investigator

Miami Cancer Institute at Baptist Health of South Florida

Eligibility Criteria

Inclusion Criteria

Timing of PBSCT: Admission for PBSCT must be within 120 days of autologous transplantation OR 80 days of the last cycle of chemotherapy.

HLA-compatible Unrelated donors Patients who do not have a related HLA-matched donor but have an unrelated donor who is matched at ≥ 9/10 (allele mismatch only) of the A, B, C, DRB1, and DQB1 loci, as tested by high resolution.

Patients aged 18-74 years at initial referral with a suitably matched related or unrelated donor who have provided their informed consent to participate in the clinical trial.

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Exclusion Criteria

Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection

Patients positive for Hepatitis B or C at risk for viral reactivation.

Pregnant or breast feeding

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Treatment Details

Interventions

Hematopoietic Stem Cells from HLA-compatible Donors (Stem Cell Transplantation)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Unrelated DonorExperimental Treatment1 Intervention

This is a phase 2 study to evaluate NMA PBSCT incorporating peri-transplant rituximab and utilizing PBSC to augment graft cell dose in patients with selected B lymphoid malignancies. Salvage chemotherapy will be required as part of transplant eligibility, both to achieve debulking of disease to allow sufficient time for the development of a post-transplant GVL effect, and to contribute to recipient immune suppression and thus facilitate donor engraftment.

Group II: HLA-compatible Related DonorExperimental Treatment1 Intervention