Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer

NCT ID: NCT00827099

Last Updated: 2012-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-11-30

Brief Summary

RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin works in treating patients with hematologic cancer.

Detailed Description

OBJECTIVES:

Primary

• To evaluate the 100-day transplant-related (non-relapse) mortality in patients with hematologic malignancies undergoing reduced-intensity conditioning comprising fludarabine phosphate, melphalan, and anti-thymocyte globulin followed by sequential umbilical cord blood transplantation (UCBT) from 2 partially-matched unrelated donors.

Secondary

• To evaluate the 12-month transplant-related (non-relapse) mortality.
• To evaluate the days to neutrophil engraftment (ANC > 500/mm³).
• To evaluate the days to platelet engraftment (platelet count > 20,000/mm³ [unsupported]).
• To evaluate the risk of acute and chronic graft-vs-host disease.
• To evaluate percent donor chimerism contribution of each cord unit.
• To evaluate relapse rate.
• To evaluate disease-free and overall survival.
• To evaluate transfusion support needed for UCBT recipients.

OUTLINE:

• Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, melphalan IV over 30-60 minutes on day -2, and anti-thymocyte globulin IV over 4-6 hours on days -4 to -2.
• Transplantation: Patients undergo two sequential umbilical cord blood transplantations on day 0.
• Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously and then orally twice daily beginning on day -1 and continuing until day 60, followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or orally twice daily beginning on day 0 and continuing until day 30, followed by a taper until day 60 in the absence of GVHD.

After completion of study treatment, patients are followed periodically.

Conditions

Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anti-thymocyte globulin

anti-thymocyte globulin

Intervention Type: BIOLOGICAL

fludarabine phosphate

fludarabine phosphate

Intervention Type: DRUG

Melphalan

melphalan

Intervention Type: DRUG

mycophenolate mofetil

mycophenolate mofetil

Intervention Type: DRUG

tacrolimus

tacrolimus

Intervention Type: DRUG

umbilical cord blood transplantation

umbilical cord blood transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Chemosensitive, non-bulky disease prior to transplant
• Multiple myeloma, meeting one of the following criteria:

• Relapsed after autologous stem cell transplantation
• Relapsed after conventional therapies AND not a candidate for autologous stem cell transplantation
• No HLA-matched related or unrelated donor available
• Has two umbilical cord blood units available that are matched at ≥ 4/6 HLA A, B, and DRB1 with the patient and with each other (HLA C and DQ will not be used in the match strategy)

• Total combined nucleated cell dose from the 2 umbilical cord blood units must be > 3.7 x 10^7 nucleated cells/kg (pre-freeze dose) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

• Karnofsky performance status 80-100%
• Adapted, weighted Charlson Comorbidity Index < 3
• Serum creatinine ≤ 2.0 mg/dL
• AST or ALT < 3 times upper limit of normal (ULN)
• Bilirubin < 1.5 times ULN
• Not pregnant or nursing
• LVEF ≥ 40%
• DLCO > 50%
• No hypoxia at rest with oxygen saturation < 92% on room air (corrected with bronchodilator therapy)
• No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral infection)
• No active hepatitis B or C infection that, in the opinion of a gastroenterologist or the transplant committee, places the patient at moderate- to high-risk for developing severe hepatic disease
• No HIV infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northside Hospital, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott R. Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Blood and Marrow Transplant Group of Georgia

Locations

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

BMTGG-NSH-801

Identifier Type: -

Identifier Source: secondary_id

CDR0000632453

Identifier Type: -

Identifier Source: org_study_id