Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

NCT00304018 | Completed Phase 1

• 4 other identifiers: CDR0000463370UCSF-02253UCSF-H24045-21269-04UCSF-2207
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and tacrolimus and prednisone after transplant may stop this from happening. PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.

Conditions

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

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalities; recurrent adult acute myeloid leukemia; secondary acute myeloid leukemia; adult acute myeloid leukemia in remission; adult acute erythroid leukemia (M6); adult acute megakaryoblastic leukemia (M7); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); refractory multiple myeloma; adult acute lymphoblastic leukemia in remission; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; stage II multiple myeloma; stage III multiple myeloma; recurrent adult acute lymphoblastic leukemia; recurrent adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; recurrent mantle cell lymphoma; stage III mantle cell lymphoma; recurrent adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; recurrent adult T-cell leukemia/lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult Hodgkin lymphoma; stage IV adult T-cell leukemia/lymphoma; stage IV mantle cell lymphoma; stage III adult T-cell leukemia/lymphoma; stage I multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies

  Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of \> 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.

  up to 24 months post-transplant

Study Arms (1)

cord blood transplant

EXPERIMENTAL

Biological: anti-thymocyte globulin; Biological: sargramostim; Drug: busulfan; Drug: etoposide; Drug: fludarabine phosphate; Drug: prednisone; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: umbilical cord blood transplantation

Interventions

anti-thymocyte globulin BIOLOGICAL

cord blood transplant

sargramostim BIOLOGICAL

cord blood transplant

busulfan DRUG

cord blood transplant

etoposide DRUG

cord blood transplant

fludarabine phosphate DRUG

cord blood transplant

prednisone DRUG

cord blood transplant

tacrolimus DRUG

cord blood transplant

allogeneic hematopoietic stem cell transplantation PROCEDURE

cord blood transplant

umbilical cord blood transplantation PROCEDURE

cord blood transplant

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following advanced hematologic malignancies: * Acute myeloid leukemia (AML) meeting the following criteria: * Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria: * High-risk cytogenetics (-7, -7q, -5, -5q, t\[6,9\], t\[9,11\], complex, Philadelphia chromosome positive \[Ph+\]) * AML evolved from prior myelodysplasia * AML secondary to prior chemotherapy * Failed to achieve remission * In second or subsequent remission * Marrow blasts ≤ 10% (may be achieved using chemotherapy) * Myelodysplastic syndromes (MDS) with high-risk features * International Prognostic Scoring System (IPSS) score intermediate -2 or high-risk * Marrow blasts ≤ 20% (may be achieved using chemotherapy) * Acute lymphoblastic leukemia meeting the following criteria: * Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria: * High-risk cytogenetics (Ph+, t\[4,11\], 11q23 abnormalities, and monosomy 7) * Required \> 1 induction course to achieve remission * Failed to achieve remission * In second or subsequent remission * Marrow blasts ≤ 10% (may be achieved using chemotherapy) * Chronic myelogenous leukemia meeting ≥ 1 of the following criteria: * Accelerated phase * Chronic phase refractory to imatinib mesylate * Blastic phase * Marrow blasts ≤ 10% (may be achieved using chemotherapy) * Multiple myeloma meeting 1 of the following criteria: * Stage II or III disease with \> first relapse or refractory disease * Newly diagnosed disease with chromosome 13 abnormalities * Lymphoma meeting the following criteria: * One of the following subtypes: * Diffuse large cell lymphoma * Mantle cell lymphoma * Peripheral T-cell lymphoma * T-natural killer (NK) cell lymphoma * Hodgkin's lymphoma * Disease failed to respond to primary therapy, progressed, or recurred after prior therapy * Patients who have failed autologous stem cell transplantation are eligible provided it has been \> 1 year since transplant * No rapid progression of malignant disease * Not eligible for autologous stem cell transplantation * Available umbilical cord blood (1-3 units) donor matching at ≥ 4 of 6 HLA antigens (A, B, and DR) * Patients with an HLA-identical or 1 antigen-mismatched related donor OR a potential HLA-matched unrelated donor matching at \> 6/8 (A, B, C, DR) alleles are not eligible PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Creatinine \< 2.0 mg/dL * Creatinine clearance \> 40 mL/min * Bilirubin \< 2.0 mg/dL * AST and alkaline phosphatase \< 3 times upper limit of normal * Hepatitis C and active hepatitis B allowed if patient has ≤ grade 2 inflammation or fibrosis by liver biopsy * Ejection fraction \> 40% by echocardiogram or MUGA * DLCO \> 40% of predicted * Not pregnant or nursing * Negative pregnancy test * No known HIV infection * No active infection requiring ongoing antibiotic treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Congenital Abnormalities; Leukemia, Myeloid, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Accelerated Phase; Blast Crisis; Leukemia, Myeloid, Chronic-Phase; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Hodgkin Disease; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Antilymphocyte Serum; sargramostim; Busulfan; Etoposide; fludarabine phosphate; Prednisone; Tacrolimus; Cord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Bone Marrow Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Myeloproliferative Disorders; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Leukemia, Lymphoid; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Macrolides; Lactones; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Thomas G. Martin, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: October 1, 2002
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

US (1)