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Chronic Myeloproliferative DisordersPhase 2NCT00005797

Bone Marrow Transplant in Treating Patients With Hematologic Cancers

A Phase 2 study testing busulfan, Cyclophosphamide and VP-16 in people with Chronic Myeloproliferative Disorders and Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Ages 15 to 55 years
What is being tested?
busulfan, Cyclophosphamide and VP-16
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteUnited States
Study dates
Mar 1993to Jul 2007
Phase
Phase 2
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 15 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of:
  • Acute myelogenous leukemia
  • Complete remission (CR) 1 - ALL except good cytogenetics defined as [(inv16, t(8,21), t(15,17)]
  • CR2
  • Induction failures
  • Relapsed OR
  • Acute lymphocytic leukemia (ALL)
  • CR1 - high risk defined as overt CNS involvement, 1 or more risk factors (age 30 and over, WBC at least 20,000/mm^3, at least 4 weeks to CR1, myeloid phenotype)
  • CR2
  • Induction failures
  • Relapsed OR
  • Chronic myelogenous leukemia
  • Chronic phase (CP) 1
  • Accelerated phase (AP)/CP2 OR
  • Chronic lymphocytic leukemia
  • At diagnosis - RAI stage III/IV or Binet C
  • Must undergo 1 induction regimen
  • Relapsed - any stage
  • Must have received no more than 3 regimens for diagnosis OR
  • Multiple myeloma
  • At diagnosis - stage II/III (primary refractory or sensitive)
  • Relapsed no more than 2 times - sensitive disease
  • Plasma cell leukemia OR
  • Myelodysplasia
  • All subtypes eligible OR
  • Myeloproliferative disorders
  • Poor response to medical therapy OR
  • Cytogenetic abnormalities
  • Must have a related donor who is genotypic 6 out of 6 HLA A, B, and DR match
  • Molecular DR matching required

PATIENT CHARACTERISTICS:

Age:

  • 15 to 55

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 3 times upper limit of normal
  • PT/PTT normal

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • LVEF at least 45% by MUGA scan or echocardiography
  • No myocardial infarction within the past 6 months
  • No arrhythmias controlled by therapy

Pulmonary:

  • FEV_1 at least 50% predicted
  • DLCO at least 50% predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • No diabetes mellitus or thyroid disease that is not medically controlled
  • No psychosocial disorder that would preclude study compliance
  • No active serious infections
  • HIV negative
  • Donor must be HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

Other trials in United States

About this study

Official title: Allogeneic Bone Marrow Transplantation for Hematologic Malignancies: A Treatment Approach Based on Risk of Relapse and Toxicity

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop 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.

PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with hematologic cancers.

Read the detailed description

OBJECTIVES:

  • Determine the progression free survival (PFS) and overall survival (OS) of patients with low risk myeloid disorders or older allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation (BMT).
  • Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide, total body irradiation, and allogeneic BMT.
  • Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease prophylaxis in these patients.
  • Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia.

OUTLINE:

  • Regimen A: Patients with chronic myelogenous leukemia (CP1, AP/CP2) and other myeloproliferative disorders, myelodysplastic disorders, acute myelogenous leukemia (CR1), or multiple myeloma (not eligible to receive total body irradiation due to prior radiation) are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation (BMT). Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Allogeneic bone marrow is infused on day 0.
  • Regimen B: Patients with acute myelogenous leukemia (at least CR2, relapsed), acute lymphoid leukemia (ALL), any acute leukemia with CNS involvement, multiple myeloma, or chronic lymphocytic leukemia are treated with total body irradiation and etoposide followed by allogeneic BMT. Patients receive total body irradiation (TBI) on days -7 to -4 for a total of 11 fractions and etoposide IV over 4 hours on day -3. Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days during TBI. Allogeneic bone marrow is infused on day 0.

Patients in both regimens receive cyclosporine and methotrexate as graft versus host disease prophylaxis.

Patients are followed weekly for 3 months and then monthly for 1 year.

PROJECTED ACCRUAL: At least 50 patients with low risk myeloid disease, 50 patients with lymphoid malignancies, and 60 patients with high risk myeloid disease will be accrued for this study.

Being tested
busulfan, Cyclophosphamide, VP-16, Fractionated Total Body Irradiation (FTBI)
Keywords
refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, polycythemia vera, primary myelofibrosis, essential thrombocythemia, refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia
Medical subject headings
Myeloproliferative Disorders, Leukemia, Multiple Myeloma, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • busulfanDrug

    Also called Busulfex®

    administered on Day -7 through Day -4. The total dose is 12.8 mg/kg

  • CyclophosphamideDrug

    administered at a dose of 60 mg/kg on each of two successive days (Days -3 and -2)

  • VP-16Drug

    Also called Etoposide (VP-16; Vepesid(R) brand only)

    administered as a single infusion on Day -3. The dose is 60 mg/kg and is calculated on actual body weight unless the patient's weight is >/= 150% of IBW, in which case adjusted body weight will be used.

  • Fractionated Total Body Irradiation (FTBI)Radiation

    FTBI is performed on day -7 through day -4. The total dose of radiation is 1,320 cGy.

Study groups in NCT00005797
Study groupRoleWhat they receive
BuCy2OtherBusulfan \& Cyclophosphamide
Receives: Drug: busulfan; Drug: Cyclophosphamide
VP16/TBIOtherFractionated Total Body Irradiation + VP-16
Receives: Drug: VP-16; Radiation: Fractionated Total Body Irradiation (FTBI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse-free survival

    Relapse free survival 5 post transplant deteremiend by the Kaplan-Meier product-limit method.

    Measured: 5 years post transplant

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 1993
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005797
Sponsor's protocol ID
MCC-11281
Other IDs
MCC-IRB-4188, NCI-G00-1759
Status last verified
Oct 2012
First submitted
2 Jun 2000
Last updated
10 Dec 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing busulfan, Cyclophosphamide and VP-16 in people with Chronic Myeloproliferative Disorders and Leukemia, run by H. Lee Moffitt Cancer Center and Research 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: finished, as of the sponsor's last update on 10 Dec 2020. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Relapse-free survival (time frame: 5 years post transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005797.

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 10 Dec 2020.

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