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Hematologic MalignanciesPhase 1NCT00477542

A Phase I Trial of Myeloablative Conditioning w/ Clofarabine and HD Busulfan for Pts w/ Refractory Heme Malignancies Undergoing Allo PBSCT

A Phase 1 study testing clofarabine in people with Hematologic Malignancies, run by Indiana University 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

This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with a myeloablative dose of busulfan. This is an initial step in developing a novel myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hematologic Malignancies
What is being tested?
clofarabine
How many people
18 participants
Where
1 siteUnited States
Study dates
May 2007to Nov 2010
Phase
Phase 1
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Documentation of disease. Patients must have one of the following disease types:
  • Acute myeloid leukemia (AML) with either:
  • Primary refractory to induction chemotherapy
  • Relapsed and refractory AML with >5% blasts in bone marrow or extramedullary disease (excluding active disease of the central nervous system).
  • Patients in second or subsequent complete remission (CR2, CR3, etc.).
  • Acute lymphoblastic leukemia (ALL) with one of the following criteria:
Show all 30Show fewer
  • Primary refractory to induction chemotherapy.
  • Relapsed and refractory ALL with >5% blasts in bone marrow or extramedullary disease (excluding active disease of the central nervous system).
  • Patients in second or subsequent complete remission (CR2, CR3, etc.).
  • Myelodysplasia, refractory anemia with excess blasts with 11-20% blasts in the bone marrow (RAEB II).
  • Chronic myelogenous leukemia (CML) with one of the following criteria:
  • Accelerated phase.
  • Patients in blast crisis.
  • Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the following criteria:
  • Failure to achieve complete remission to primary induction therapy
  • Relapsed NHL, refractory to at least one line of salvage systemic therapy
  • Patients who relapse < 6 months following autologous stem cell transplantation are not eligible.
  • Patient age 18-60 years
  • Availability of a consenting HLA-matched donor
  • Performance status ECOG 0-1
  • No active infection. Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
  • No HIV disease. Patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.
  • Non-pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks. Women of childbearing potential should have a negative pregnancy test prior to study entry. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom).
  • Required baseline laboratory values:
  • LVEF > 45% corrected
  • DLCO > 50% of predicted value (corrected for hemoglobin)
  • Serum creatinine ≤ 2.0 mg/dl or estimated creatinine clearance of ≥60 ml/min
  • Bilirubin < 1 x upper limit of normal value
  • AST and ALT < 1 x upper limit of normal value
  • Signed written informed consent. Patient must be capable of understanding the investigational nature of the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.

Who cannot join

  • Patients who relapse < 6 months following autologous stem cell transplantation are not eligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Phase I Trial of Myeloablative Conditioning Using Clofarabine and High-Dose Busulfan for Patients With Refractory Hematological Malignancies Undergoing Allogeneic HSCT

This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with a myeloablative dose of busulfan. This is an initial step in developing a novel myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). While this phase I trial will initially develop the regimen in patients with refractory disease, it is expected that it will find its best application in patients with less advanced disease

Read the detailed description

All patients will receive the same dose of busulfan. The dose of clofarabine will be escalated in successive cohorts of patients. Using a standard dose escalation design, successive cohorts of 3 patients will be treated with escalating doses of clofarabine. At the MTD (or highest dose-level if the MTD is not reached), the cohort will be expanded to 10 patients to better investigate correlative studies and give some preliminary idea of efficacy.

Being tested
clofarabine
Keywords
Clofarabine, allogeneic HSCT, refractory malignancies
Medical subject headings
Hematologic Neoplasms, Neoplasms

What participants receive

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

  • clofarabineDrug

    Cohort- n- Clofarabine (mg/m2/day)

    -1 3-10 20

    1. 3-6 30
    2. 3-6 40
    3. 3-6 50
    4. 3-6 60
    5. 6-10 70

What is being measured

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

  1. Determine the MTD of clofarabine in association with a myeloablative dose of busulfan as a preparative regimen in patients with refractory hematological malignancies undergoing allogeneic HSCT.

    Measured: 1 year

Secondary outcomes (1)

  1. • Assessment of the toxicity of the combination of clofarabine and busulfan • Assess clofarabine and busulfan pharmacokinetics with combination therapy • Describe the response rate • Describe relapse rate and event-free survival

    Measured: 1 year

Timeline

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

  1. First posted23 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionNov 2010
  4. Study completionNov 2010

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00477542
Sponsor's protocol ID
0704-30 IUCRO-0186
Status last verified
Sep 2014
First submitted
21 May 2007
Last updated
18 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing clofarabine in people with Hematologic Malignancies, run by Indiana University 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?

The sponsor lists 30 inclusion and 1 exclusion criteria. 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 18 Sep 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Determine the MTD of clofarabine in association with a myeloablative dose of busulfan as a preparative regimen in patients with refractory hematological malignancies undergoing allogeneic HSCT. (time frame: 1 year). 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 NCT00477542.

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 18 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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