Stem Cell Transplant for Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byKenneth Meehan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Dartmouth-Hitchcock Medical Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The standard Johns Hopkins' regimen will be used in study subjects, with the use of donor peripheral blood stem cells, rather than marrow. Clinical outcomes will be defined while focusing efforts on immune reconstitution focusing on immune checkpoint regulators after a related haploidentical stem cell transplant.

Research Team

Kenneth Meehan, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for people under 75 with certain blood cancers like various leukemias, lymphomas, and myeloma who might benefit from a stem cell transplant. They need to have a related donor that's a partial genetic match (haploidentical), be in decent physical shape without major organ failure or active infections, and not have HIV or hepatitis B/C.

Inclusion Criteria

My major organs are functioning well enough for a transplant.

I have a family member who is a match for my transplant.

I do not have HIV, hepatitis B, or hepatitis C.

See 10 more

Exclusion Criteria

I do not have a major illness or organ failure that would prevent me from surviving a transplant.

I have had infections that didn't respond to treatment.

Psychiatric disorder or mental deficiency affecting compliance and informed consent

Treatment Details

Interventions

cellcept (Immunosuppressant)
Cyclophosphamide (Alkylating agents)
Fludarabine (Anti-metabolites)
g-csf (Growth Factor)
Peripheral Blood Transplant (Procedure)
Tacrolimus (Calcineurin Inhibitor)
Total Body Irradiation (Radiation)

Trial OverviewThe study tests the standard Johns Hopkins' regimen using donor peripheral blood stem cells instead of marrow for transplants. It aims to observe clinical outcomes and how immune checkpoint regulators behave after the transplant in patients with specific blood disorders.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Johns Hopkins' conditioning regimenExperimental Treatment7 Interventions

Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant

Cyclophosphamide is already approved in Canada, Japan for the following indications: