NCT00301951

Brief Summary

RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem 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 chemotherapy, such as fludarabine and busulfan, and antithymocyte globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Sep 2004

Typical duration for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

4.8 years

First QC Date

March 9, 2006

Last Update Submit

October 10, 2017

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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)accelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionangioimmunoblastic T-cell lymphomablastic phase chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissueanaplastic large cell lymphomanodal marginal zone B-cell lymphomapreviously treated myelodysplastic syndromesrecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult T-cell leukemia/lymphomarecurrent adult Hodgkin lymphomarecurrent adult diffuse large cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent small lymphocytic lymphomarefractory chronic lymphocytic leukemiastage III adult T-cell leukemia/lymphomarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromessplenic marginal zone lymphomastage I multiple myelomastage II multiple myelomastage IV adult T-cell leukemia/lymphomastage III adult Hodgkin lymphomastage III adult diffuse large cell lymphomastage III chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III multiple myelomastage III small lymphocytic lymphomastage IV adult Hodgkin lymphomastage IV adult diffuse large cell lymphomastage IV chronic lymphocytic leukemiastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

  • Safety and Feasibility of donor cord blood transplant

    as determined by \> 80% engraftment rate at day 180 and a \< 50% transplant-related mortality rate at day 100

    up to 36 months post transplant

Study Arms (1)

cord blood transplant

EXPERIMENTAL
Biological: anti-thymocyte globulinBiological: sargramostimDrug: busulfanDrug: fludarabine phosphateDrug: mycophenolate mofetilDrug: tacrolimusProcedure: umbilical cord blood transplantation

Interventions

anti-thymocyte globulinBIOLOGICAL
cord blood transplant
sargramostimBIOLOGICAL
cord blood transplant
busulfanDRUG
cord blood transplant
fludarabine phosphateDRUG
cord blood transplant
mycophenolate mofetilDRUG
cord blood transplant
tacrolimusDRUG
cord blood transplant
umbilical cord blood transplantationPROCEDURE
cord blood transplant

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following advanced hematologic malignancies: * Acute myeloid leukemia (AML) meeting the following criteria: * Considered incurable with chemotherapy * Marrow blasts ≤ 10% (may be achieved using standard chemotherapy regimen) * Meets any of the following criteria: * High-risk cytogenetics (-7, -7q, -5, -5q, t(6,9), t(9,11), complex \[≥ 3 abnormalities\], Philadelphia chromosome positive \[Ph+\]) * AML evolved from prior myelodysplasia * AML secondary to prior chemotherapy * Failed to achieve remission * In second or subsequent remission * Refractory relapse * Myelodysplastic syndromes (MDS) meeting the following criteria: * Must have high-risk features, including any of the following: * Intermediate-2 or high risk International Prognostic Scoring System (IPSS) score * Chronic myelomonocytic leukemia * Marrow blasts ≤ 20% (chemotherapy may be given to achieve target blast levels) * No rapidly progressive disease * Acute lymphoblastic leukemia meeting the following criteria: * Considered incurable with chemotherapy * Meets any of the following criteria: * High-risk cytogenetics (Ph+, t(4,11), 11q23 abnormalities, or monosomy 7) * Required \> 1 induction course to achieve remission * Failed to enter remission * In second or subsequent remission * Marrow blasts ≤ 10% (chemotherapy may be given to achieve target blast levels) * Chronic myelogenous leukemia (CML) meeting 1 of the following criteria: * Chronic phase CML that failed imatinib mesylate therapy, as defined by progressive disease or failed to achieve a major cytogenetic response at 1 year after initiation of therapy * Accelerated phase CML meeting 1 of the following criteria: * Failed to achieve a complete cytogenetic remission at 1 year after initiation of therapy * Failed to achieve any cytogenetic response after 6 months of therapy * Progressive disease, as demonstrated by worsening cytogenetic response in 2 consecutive analyses separated by 4 weeks * In blast crisis with \< 10% blasts in bone marrow * Multiple myeloma meeting the following criteria: * Stage I-III disease * Meets any of the following criteria: * In relapse after autologous transplantation * Refractory to ≥ 2 prior conventional myeloma therapies * Chromosome 13 abnormalities (may be enrolled at diagnosis or after initial progression) * Lymphoma * The following subtypes are eligible: * Diffuse large cell * Follicular large cell * Mantle cell * Peripheral T-cell * T-natural killer (T-NK) cell * Hodgkin's lymphoma * Must have progressed, recurred after prior therapy, or failed to respond to primary therapy * Relapsed disease after autologous stem cell transplantation (SCT) allowed * Low-grade non-Hodgkin's lymphoma meeting 1 of the following criteria: * Relapsed or refractory disease after ≥ 2 chemotherapy-based treatment regimens * Relapsed after autologous SCT * Chronic lymphocytic leukemia * Relapsed or refractory disease after ≥ 2 chemotherapy-based treatment regimens * Relapsed after autologous SCT * Meets 1 of the following criteria: * Age 55-70 years * Under age 55 and deemed ineligible for conventional high-dose chemotherapy, as indicated by any of the following: * Poor cardiac function (i.e., LVEF \< 40%) * Poor pulmonary function (i.e., DLCO \< 50%) * Hepatic dysfunction * Prior myeloablative therapy * Not eligible for autologous SCT or conventional therapy * Umbilical cord blood donor available * Matched at ≥ 4 of 6 HLA antigens (A, B, and DR) * Has 1-3 units of umbilical cord blood available * Must not have an HLA-identical or 1 antigen mismatched related donor or potential HLA-matched unrelated donor readily available 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: * ECOG performance status 0-2 * Creatinine clearance \> 40 mL/min * Creatinine \< 2.0 mg/dL * AST and alkaline phosphatase \< 3 times upper limit of normal (ULN) * Bilirubin \< 2.0 mg/dL * Hepatitis C or active hepatitis B virus (HBV) allowed if ≤ grade 2 fibrosis and/or inflammation by liver biopsy * Patients with history of HBV infection should be tested for hepatitis B epsilon (HBe) antigen, anti-HBe, and HBV DNA (quantitative) * Patients with active HBV viral replication should receive antiviral therapy * Ejection fraction \> 30% * DLCO ≥ 40% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring ongoing antibiotic treatment * HIV negative 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

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0324, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseImmunoblastic LymphadenopathyBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZonePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Antilymphocyte SerumsargramostimBusulfanfludarabine phosphateMycophenolic AcidTacrolimusCord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphadenopathyCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyelodysplastic-Myeloproliferative DiseasesLymphoma, T-CellLymphoma, Non-HodgkinLymphoma, B-CellLeukemia, LymphoidLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsMacrolidesLactonesStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Thomas G. Martin, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

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 9, 2006

First Posted

March 13, 2006

Study Start

September 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

US(1)