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NCT00556452 · REGISTRY CONDITION SEARCH

Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2017-12-05

The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for stem cell transplant in the treatment of aggressive hematologic malignancies in subjects where more conventional approaches are failing.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Regimen Related Toxicities

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outcome · POSTED

One-year Overall Survival Rate for AML

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outcome · POSTED

Two-year Overall Survival for All Cases.

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outcome · POSTED

Five Year Overall Survival for All Cases

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: Disease Criteria * Acute leukemia or chronic myelogenous leukemia in blastic crisis or accelerated phase, not in remission at the time of transplant * Myelodysplastic syndrome, with more than 5% blasts in bone marrow at the time of transplant * Hodgkin and Non-Hodgkin Lymphomas: Not in CR in PET scan or CT scan before transplant, or relapsed within 1 year from previous remission * CLL not in remission * Multiple Myeloma, not in remission * Suitable donor available (related or unrelated) Age, Organ Function Criteria * Age: ≤ 70 years * Cardiac: LV Ejection Fraction ≥ 40% by MUGA or Echocardiogram * Pulmonary: FEV1 and FVC ≥ 40% predicted, and DLCO (corrected for hemoglobin) ≥ 40% of predicted * Renal: Adult population: serum creatinine ≤ 1.0 mg/dL (if serum creatinine \> 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be \> 60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation) * Renal: Pediatric population: serum creatinine clearance ≥ 90 ml/min/1.73 m2 as calculated by the Schwartz formula for estimated GFR * Hepatic: serum total bilirubin ≤ 2.0 mg/dl and AST / ALT ≤ ULN x 4 * Performance status: Karnofsky ≥ 70% Exclusion Criteria: * Other active life-threatening cancer requiring treatment other than allo-HSCT * HIV1 or HIV2 positive * Uncontrolled medical or psychiatric disorder * Uncontrolled viral or fungal infection * Active CNS leukemia * Non-compliant to medications * No appropriate caregivers identified
healthy Volunteers
false
maximum Age
70 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment. After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.
    intervention Names
    1. Drug: Clofarabine/Busulfan x 4
    2. Procedure: Peripheral blood stem cell transplant
    3. Radiation: Total Lymphoid Irradiation
    label
    Clo/BU4
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Clo/BU4
    description
    Clofarabine IV (dose levels) * 1st dose level: 20 mg/m2/day x 5 days * 2nd dose level: 30 mg/m2/day x 5 days * 3rd dose level: 40 mg/m2/day x 5 days Busulfan IV 3.2 mg/kg daily x 4 days
    name
    Clofarabine/Busulfan x 4
    type
    DRUG
  2. arm Group Labels
    1. Clo/BU4
    description
    Peripheral blood stem cell transplant, after pre-conditioning drug treatment
    name
    Peripheral blood stem cell transplant
    type
    PROCEDURE
  3. arm Group Labels
    1. Clo/BU4
    description
    Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant
    name
    Total Lymphoid Irradiation
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
46
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The incidence of non-hematological toxicities (Common Terminology Criteria for Adverse Events (CTCAE) 3.0) from initiation of conditioning to Day + 30 or toxicities after day +30, possibly, probably or definitely related to conditioning for all patients treated with Clofarabine (independent of dose level).
    measure
    Regimen Related Toxicities
    time Frame
    two years
  2. description
    Percent Overall Survival (OS) for at one year for subjects with Acute Myeloid Leukemia (AML).
    measure
    One-year Overall Survival Rate for AML
    time Frame
    1 year
secondary Outcomes
  1. description
    Percent Overall Survival (OS) at two years for all patients.
    measure
    Two-year Overall Survival for All Cases.
    time Frame
    2 years
  2. description
    The number of patients alive at 5 years
    measure
    Five Year Overall Survival for All Cases
    time Frame
    five years
Full study description
brief Summary
The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for stem cell transplant in the treatment of aggressive hematologic malignancies in subjects where more conventional approaches are failing.
detailed Description
Transplants with stem cells collected from the blood of an unrelated donor (allo-HSCT) are being used more commonly for many blood cancers which are not curable with more conventional methods of chemotherapy. Although allo-HSCT has great potential, there are still high risks due to infections, graft-versus-host disease (GVHD), where the donor's cells attack the recipient's tissues as foreign, and due to toxic effects of the chemotherapy drugs given to prepare (or condition) the recipient's bone marrow for transplant. As a reduced intensity conditioning, a combination of Fludarabine and a lower dose of Busulfan (Flu/BU2) is one of the most popular regimens. Among full-intensity regimens, a combination of Fludarabine and standard-dose Busulfan (Flu/BU4) has been investigated recently and shown to be very well tolerated. Clofarabine, similar to Fludarabine, is known to have a stronger anti-tumor effect than Fludarabine and has shown promise in treating aggressive acute leukemias. In addition, evidence is that it is well-tolerated with manageable side effects especially in older subjects. Thus replacing Fludarabine with Clofarabine in a full-intensity transplant regimen, Clo/BU4 may provide a regimen with increased anti-tumor activity without adding significant risks of toxicity. The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity regimen (Clo/BU4) and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for HSCT in the treatment for aggressive hematologic malignancies, in subjects where more conventional approaches are failing.
Source references
references
  1. citation
    Magenau J, Tobai H, Pawarode A, Braun T, Peres E, Reddy P, Kitko C, Choi S, Yanik G, Frame D, Harris A, Erba H, Kujawski L, Elenitoba-Johnson K, Sanks J, Jones D, Paczesny S, Ferrara J, Levine J, Mineishi S. Clofarabine and busulfan conditioning facilitates engraftment and provides significant antitumor activity in nonremission hematologic malignancies. Blood. 2011 Oct 13;118(15):4258-64. doi: 10.1182/blood-2011-06-358010. Epub 2011 Aug 12.
    pmid
    21841163
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice