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Stem Cell Transplant

Stem Cell Transplant for Leukemia

Phase 2

Waitlist Available

Led By Guenther Koehne, MD, PhD

Research Sponsored by Guenther Koehne

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

No Placebo-Only Group

Summary

This trial will see if an investigational device helps reduce complications for blood stem cell transplants.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include those related to chemotherapy and radiation such as nausea/vomiting, fatigue, hair loss; organ toxicity affecting the heart/liver/kidneys/lungs; increased infection risk due to immune suppression; graft-versus-host disease from the transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two 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

Change in disease free survival (DFS)

Change in overall survival (OS)

Incidence of transplant-related mortality (TRM)

+2 more

Secondary study objectives

Proportion of patients optimal and suboptimal doses

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: 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melphalan

2008

Completed Phase 3

~1500

Total Body Irradiation (TBI)

2016

Completed Phase 3

~1220