Advanced Hematologic MalignanciesPhase 1/2NCT00943592
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
A Phase 1/2 study testing Clofarabine, Melphalan and Campath in people with Advanced Hematologic Malignancies and Leukemia, run by University of Chicago at 1 site in United States.
Trial summary
This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hematologic Malignancies, Leukemia, Preleukemia
- What is being tested?
- Clofarabine, Melphalan and Campath
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Nov 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory acute myelogenous or lymphoid leukemia
- Chronic myelogenous leukemia in accelerated phase or blast-crisis
- Chronic myelogenous leukemia in second or subsequent chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
- Multiple myeloma at high risk for disease recurrence
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features
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- Other Myeloproliferative disorder (polycythemia vera, essential thrombocythemia, myelofibrosis) with poor prognostic features
- Myelodysplastic syndromes (including PNH) with > 5% blasts
- Zubroid performance status < 2 (See Appendix B)
- Life expectancy is not severely limited by concomitant illness
- Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
- Calculated Creatinine Clearance > 50 ml/min
- Serum bilirubin 2.0 mg/dl, SGPT < 3x upper limit of normal
- No evidence of chronic active hepatitis or cirrhosis
- HIV-negative
- Patient is not pregnant
- Patient or guardian able to sign informed consent
Who cannot join
- Clinical progression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.
- Conditions
- Advanced Hematologic Malignancies, Leukemia, Preleukemia
- Being tested
- Clofarabine, Melphalan, Campath, Stem Cell Transplant
- Keywords
- Melphalan, Alemtuzumab, Clofarabine
- Medical subject headings
- Leukemia, Preleukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClofarabineDrug
Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).
MelphalanDrug
Doses ranging from 100 to 140 mg/m2
CampathDrug
20mg/d x5
Stem Cell TransplantProcedure or surgery
Infusion of donor, bone marrow and auto.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Clofarabine; Drug: Melphalan; Drug: Campath; Procedure: Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Measured: Day 7 until Day 30
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Measured: Day 7 until Day 30
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Measured: Day 7 until Day 30
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Measured: Day 7 until Day 30
Secondary outcomes (4)
Overall Survival (OS)
Measured: 1 year
Progression-free Survival (PFS)
Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.
Measured: 1 year
Treatment-related Mortality (TRM)
Measured: 1 year
Relapse Rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startMar 2006
- Primary completionApr 2011
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Artz, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943592
- Sponsor's protocol ID
- 14341B
- Status last verified
- Jan 2014
- First submitted
- 20 Jul 2009
- Last updated
- 27 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00943592
- Acronym / sponsor ID
- 14341B
- Conditions
- Advanced Hematologic Malignancies, Leukemia, Preleukemia
- Keywords
- Melphalan, Alemtuzumab, Clofarabine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Posted 27 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Clofarabine, Drug: Melphalan, Drug: Campath, Procedure: Stem Cell Transplant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Relapsed or refractory acute myelogenous or lymphoid leukemia
- Chronic myelogenous leukemia in accelerated phase or blast-crisis
- Chronic myelogenous leukemia in second or subsequent chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
- Multiple myeloma at high risk for disease recurrence
Key exclusion criteria (1 listed)
- Clinical progression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClofarabineClofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels). | Drug | Treatment |
| MelphalanDoses ranging from 100 to 140 mg/m2 | Drug | Treatment |
| Campath20mg/d x5 | Drug | Treatment |
| Stem Cell TransplantInfusion of donor, bone marrow and auto. | Procedure or surgery | Treatment |
Primary outcome
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Time frame: Day 7 until Day 30
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Time frame: Day 7 until Day 30
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Time frame: Day 7 until Day 30
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Time frame: Day 7 until Day 30
Toxicity was scored according to NCI/CTC version 3
4 secondary outcomes
Overall Survival (OS)
Time frame: 1 year
Progression-free Survival (PFS)
Time frame: 1 year
Treatment-related Mortality (TRM)
Time frame: 1 year
Relapse Rate
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Artz, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clofarabine, Melphalan and Campath in people with Advanced Hematologic Malignancies and Leukemia, run by University of Chicago 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 17 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 27 Feb 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation (time frame: Day 7 until Day 30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 27 Feb 2014.