Reduced Intensity Double Umbilical Cord Blood Transplantation

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Hodgkin's Lymphoma; Acute Myelogenous Leukemia; Multiple Myeloma; Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Radiation: Total Body Radiation; Biological: Cord Blood; Drug: Fludarabine; Drug: Melphalan

Study type: Interventional

Funder types: Other

Identifiers

NCT01408563

11-085

Details and patient eligibility

About

This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells.

Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.

Full description

Subjects will receive their transplants as in-patients.

• IV-Catheter

  • one or two IV catheters will be placed on the day of hospital admission

• Conditioning

  • Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)
  • Melphalan IV (day -1)
  • Total body radiation on day 0 (same day as transplant)

• Immunosuppressive Therapy

  • Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient

• Infusion of Cord Blood units

  • 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be provided

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
• Appropriate candidate for reduced intensity regimen, according to the treating physician
• Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
• Able to comply with the requirements for care after allogeneic stem cell transplantation

Exclusion criteria

• Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
• Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
• Renal disease
• Hepatic disease
• Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
• HIV-positive
• Uncontrolled infection
• Pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Fludarabine/Melphalan/TBI

Experimental group

Description:

All patients receive same therapy

Treatment:

Drug: Melphalan

Radiation: Total Body Radiation

Drug: Fludarabine

Biological: Cord Blood