Stem Cell Transplant for Leukemia

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: Guenther Koehne

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.

Eligibility Criteria

This trial is for adults aged 18-74 with certain types of leukemia or lymphoma, such as AML not in 'good risk' remission, ALL/CLL at high relapse risk or second remission, CML unresponsive to specific drugs, and some non-Hodgkin's lymphomas. Participants need a performance status of ≥70%, no active infections or HIV/HTLV, not pregnant/breastfeeding, and must have good heart, liver, kidney and lung function.

Treatment Details

The study tests if using the CliniMACS system to process blood stem cell transplants can reduce complications in patients with blood cancers/disorders. It involves conditioning treatments like TBI (Total Body Irradiation), Thiotepa, Cyclophosphamide among others before transplanting CD34+ selected cells.

2Treatment groups

Experimental Treatment

Group I: Regimen B: Busulfan/Melphalan/FludarabineExperimental Treatment3 Interventions

Patients in enrolled in Regimen B will receive the following: * Busulfan, IV 0.8 mg/kg q6hours x 10 or 12 doses over 3 days, depending on the disease * Melphalan, 70 mg/m\^2/day x 2 days via IV infusion over 30 minutes daily * Fludarabine, 25 mg/m\^2/day x 5 days via IV infusion over 30 minutes daily

Group II: Regimen A: TBI/Thiotepa/CyclophosphamideExperimental Treatment3 Interventions

Patients in enrolled in Regimen A will receive the following: * Total Body Irradiation (TBI), hyper-fractionated to a dose of 1320 cGy depending on age, stage of disease and requirement of general anesthesia with lung shielding * Thiotepa, 5 mg/kg/day x 2 days via IV infusion over 4 hours daily or 10 mg/kg on one day * Cyclophosphamide, 60 mg/kg/day x 2 days via IV infusion over 2 hours daily (or if cyclophosphamide is contraindicated, fludarabine at 25 mg/m\^2 x 5 days may be substituted)