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LeukemiaNCT00423826

Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

A study testing Busulfan, Cytarabine and Fludarabine phosphate in people with Leukemia and Lymphoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Ages Up to 69 years
What is being tested?
Busulfan, Cytarabine and Fludarabine phosphate
How many people
Not given
Where
1 siteUnited States
Study dates
Jan 2007to Jan 2015
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 69 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:
  • Acute myeloid leukemia meeting the following criteria:
  • M0-M7 histologic subtypes by French-American-British classification
  • Previously treated disease
  • Meets 1 of the following criteria:
  • Persistent disease as evidenced by 5-30% persistent blasts in bone marrow after induction or salvage therapy
  • In second or subsequent complete remission (CR)
  • In first CR with 1 of the following high-risk features:
  • Philadelphia chromosome present
  • Noncore-binding factor type of chromosomal abnormalities
  • Myelodysplastic syndromes with 1 of the following International Prognostic Scoring System (IPSS) scores:
  • Intermediate-1
  • Intermediate-2
  • High-risk score with transfusion dependence
  • Chronic myelogenous leukemia meeting 1 of the following criteria:
  • In accelerated or blastic phase
  • Failed prior imatinib mesylate therapy
  • Acute lymphoblastic leukemia meeting 1 of the following criteria:
  • In first CR with any of the following high-risk features:
  • Philadelphia chromosome present
  • Translocation t(4;11) present
  • WBC > 30,000/mm³ (adult patients)
  • More than 4 weeks from initiation of treatment was required to achieve CR (adult patients)
  • DNA index of near haploid (N=23 chromosomes) (pediatric patients)
  • In second or subsequent CR
  • Persistent disease as evidenced by 5-20% persistent blasts in bone marrow after induction or salvage therapy
  • Hodgkin's or non-Hodgkin's lymphoma meeting the following criteria:
  • Recurrent or refractory disease
  • Tumor ≤ 5 cm in diameter
  • Myeloma or plasma cell neoplasm meeting 1 of the following staging criteria:
  • Stage III at presentation
  • Stage I-II at presentation
  • Not responding OR progressed after first-line therapy
  • Chronic lymphocytic leukemia or Waldenstrom's macroglobulinemia with refractory or progressive disease after first-line therapy
  • No 5-6/6 HLA-matched related or 7-8/8 HLA-matched unrelated marrow or peripheral blood stem cell donor available
  • No single 4-6/6 HLA-A, -B, or -DRB1-matched umbilical cord blood unit ≥ 3.5 x 10^7 nucleated cells/kg available

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky or Lansky PS 70-100%
  • Not pregnant
  • Fertile patients must use effective contraception prior to and during study participation
  • HIV negative
  • Bilirubin < 3.0 mg/dL
  • AST and ALT ≤ 3 times upper limit of normal
  • Creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min
  • Cardiac ejection fraction > 50% by echocardiogram OR shortening fraction > 27%
  • No uncontrolled symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • FEV_1 > 50% of normal
  • Forced vital capacity > 50% of normal
  • DLCO normal
  • Oxygen saturation > 92% on room air (for patients < 5 years of age)
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to busulfan and fludarabine phosphate
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior and no concurrent surgery
  • At least 4 weeks since prior and no other concurrent investigational or commercial agents or therapies for the malignancy, including chemotherapy, biologic therapy, or radiotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

Other trials in United States

About this study

Official title: A Pilot Study of Double Cord Blood Stem Cell Transplantation in Patients With Hematologic Malignancies

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also stops 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 or abnormal 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 before the transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant works in treating patients with hematologic cancer or other disease.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy of double umbilical cord blood stem cell transplantation using a conditioning regimen comprising lower doses of busulfan and fludarabine phosphate and low-dose total body irradiation, in terms of stem cell engraftment at 60 days post transplantation, in patients with hematologic cancer or other diseases.
  • Determine the merits of conducting a larger, comparative study of this regimen.

Secondary

  • Determine mortality within 100 days of transplantation in these patients.

OUTLINE: This is a pilot study.

  • Reduced-intensity conditioning regimen: Patients receive busulfan IV over 3 hours on days -9 to -8 and fludarabine phosphate IV on days -7 to -3. Patients then undergo low-dose total body irradiation on day 0.
  • Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV twice daily and mycophenolate orally or IV three times daily beginning on day -3.
  • CNS prophylaxis and/or treatment: Patients with a history of CNS involvement receive prophylactic cytarabine (Ara-C) intrathecally (IT) prior to transplant. Patients also undergo lumbar puncture (LP) to test for active CNS disease. Patients with cerebrospinal fluid positive for leukemia receive Ara-C IT every 2-3 days until a repeat LP shows no remaining leukemic cells. Three days after the last LP and after one final dose of Ara-C, patients begin the conditioning regimen.
  • Double umbilical cord blood (UCB) donor stem cell transplantation (SCT): Patients undergo double UCB donor SCT on day 0.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Keywords
accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission, recurrent childhood acute lymphoblastic leukemia, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, 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), recurrent adult acute myeloid leukemia, adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), adult acute myelomonocytic leukemia (M4)
Medical subject headings
Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Precancerous Conditions, Leukemia, Myeloid, Accelerated Phase, Blast Crisis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BusulfanDrug

    Also called Busulfex®, Myleran®

    3 mg/kg intravenously over 3 hours

  • CytarabineDrug

    Also called DepoCyt(TM), Liposomal Ara-C

    Patients with previous history of CNS involvement will receive pre-transplant intrathecal Cytarabine (Ara-C) (30 mg/M2) therapy.

  • Fludarabine phosphateDrug

    Also called Fludara

    25 mg/M2/day IV

  • mycophenolate mofetilDrug

    Also called Cellcept

    Orally at the dose of 1 gm every 8 hours.

  • tacrolimusDrug

    Also called Advagraf, Prograf, Protopic

    0.015 mg/kg IV every 12 hours by continuous infusion.

  • allogeneic hematopoietic stem cell transplantationProcedure or surgery

    10 days post drug intervention

  • umbilical cord blood transplantationProcedure or surgery

    10 days post drug intervention

  • total-body irradiationRadiation

    10 days post drug intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423826
Sponsor's protocol ID
CDR0000518230
Other IDs
P30CA022453, WSU-2006-059, WSU-112506MP2F
Status last verified
Feb 2016
First submitted
16 Jan 2007
Last updated
29 Feb 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Busulfan, Cytarabine and Fludarabine phosphate in people with Leukemia and Lymphoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.

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