LeukemiaPhase 1/2NCT00002761
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
A Phase 1/2 study testing filgrastim, recombinant interferon gamma and busulfan in people with Leukemia, run by Columbia University.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- filgrastim, recombinant interferon gamma and busulfan
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 1996to Oct 2007
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia in first chronic phase Philadelphia chromosome-positive Myelofibrosis less than 3+ on bone marrow biopsy Ineligible for allogeneic transplantation No suitable allogeneic sibling donor OR Under 55 years old but refuses unrelated donor transplantation or no unrelated donor available
PATIENT CHARACTERISTICS: Age: 18 to physiologic 60 Performance status: ECOG 0-1 Hematopoietic: See Disease Characteristics WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 times normal (unless elevation due to Gilbert's disease) SGOT less than 1.5 times normal Renal: Creatinine less than 1.5 times normal Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: DLCO at least 60% predicted Other: HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon alfa Chemotherapy: No concurrent conventional chemotherapy Endocrine therapy: No concurrent steroids during chemotherapy Radiotherapy: Not specified Surgery: Not specified Other: No concurrent barbiturates or acetaminophen during chemotherapy
About this study
Official title: CAMP-010: PHASE I/II STUDY OF IN VIVO PURGING FOLLOWED BY HIGH DOSE CHEMOTHERAPY, AUTOLOGOUS HEMATOPOIETIC STEM CELL INFUSION AND IMMUNOTHERAPY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.
Read the detailed description
OBJECTIVES: I. Determine whether intensive idarubicin and cytarabine leads to adequate harvest of Philadelphia chromosome-negative peripheral blood stem cells (PBSC) in patients with chronic myelogenous leukemia in chronic phase. II. Determine the toxicity of this intensive regimen in these patients. III. Determine the graft-versus-leukemia effect induced in these patients by cyclosporine and interferon gamma post-PBSC transplantation. IV. Determine the transformation-free and overall survival in patients treated with a high-dose conditioning regimen comprising busulfan and cyclophosphamide followed by PBSC transplantation plus immunotherapy.
OUTLINE: Patients receive idarubicin IV and cytarabine IV over 2 hours on days 1-3. When blood counts recover, Philadelphia chromosome negative peripheral blood stem cells (PBSC) are harvested. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of cytarabine infusion and continuing until blood counts have recovered for 3 consecutive days after harvest of PBSC. Patients with more than 5% blasts in marrow or any peripheral blasts, interferon resistance, interferon intolerance with poor prognosis, and clonal evolution proceed to conditioning followed by PBSC transplantation. Patients receive conditioning comprising oral busulfan every 6 hrs on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 and -3. PBSC are reinfused on day 0. Patients receive graft versus leukemia induction comprising cyclosporine IV over 4 hours every 12 hours on days 0-28 and interferon gamma SC beginning on day 7 and continuing every other day through day 28. Patients are followed every 3 months for 1 year and then annually for 5 years.
PROJECTED ACCRUAL: A total of 15-43 patients will be accrued for this study within 4-8 years.
- Conditions
- Leukemia
- Being tested
- filgrastim, recombinant interferon gamma, busulfan, cyclophosphamide, cyclosporine
- Keywords
- relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
recombinant interferon gammaBiological
busulfanDrug
cyclophosphamideDrug
cyclosporineDrug
cytarabineDrug
idarubicinDrug
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2003 (estimated)
- Study startFeb 1996
- Primary completionFeb 2007
- Study completionOct 2007
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Investigators
- Gwen L. Nichols, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002761
- Sponsor's protocol ID
- AAAA7158
- Other IDs
- CU-CAMP-10, NCI-V96-0873
- Status last verified
- Nov 2012
- First submitted
- 1 Nov 1999
- Last updated
- 19 Nov 2012
- Results posted
- No
Publications
Papadopoulos KP, Nichols G: Autologous peripheral blood progenitor (PBPC) transplantation in patients with chronic myeloid leukemia. Biol Blood Marrow Transplant 4(2): A-55, 109, 1998.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMP-010: PHASE I/II STUDY OF IN VIVO PURGING FOLLOWED BY HIGH DOSE CHEMOTHERAPY, AUTOLOGOUS HEMATOPOIETIC STEM CELL INFUSION AND IMMUNOTHERAPY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA
- ClinicalTrials.gov ID
- NCT00002761
- Acronym / sponsor ID
- AAAA7158
- Conditions
- Leukemia
- Keywords
- relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Feb 1996
- Primary completion
- Feb 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 24 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.
Detailed description
OBJECTIVES: I. Determine whether intensive idarubicin and cytarabine leads to adequate harvest of Philadelphia chromosome-negative peripheral blood stem cells (PBSC) in patients with chronic myelogenous leukemia in chronic phase. II. Determine the toxicity of this intensive regimen in these patients. III. Determine the graft-versus-leukemia effect induced in these patients by cyclosporine and interferon gamma post-PBSC transplantation. IV. Determine the transformation-free and overall survival in patients treated with a high-dose conditioning regimen comprising busulfan and cyclophosphamide followed by PBSC transplantation plus immunotherapy.
OUTLINE: Patients receive idarubicin IV and cytarabine IV over 2 hours on days 1-3. When blood counts recover, Philadelphia chromosome negative peripheral blood stem cells (PBSC) are harvested. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of cytarabine infusion and continuing until blood counts have recovered for 3 consecutive days after harvest of PBSC. Patients with more than 5% blasts in marrow or any peripheral blasts, interferon resistance, interferon intolerance with poor prognosis, and clonal evolution proceed to conditioning followed by PBSC transplantation. Patients receive conditioning comprising oral busulfan every 6 hrs on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 and -3. PBSC are reinfused on day 0. Patients receive graft versus leukemia induction comprising cyclosporine IV over 4 hours every 12 hours on days 0-28 and interferon gamma SC beginning on day 7 and continuing every other day through day 28. Patients are followed every 3 months for 1 year and then annually for 5 years.
PROJECTED ACCRUAL: A total of 15-43 patients will be accrued for this study within 4-8 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| filgrastim | Biological | – |
| recombinant interferon gamma | Biological | – |
| busulfan | Drug | – |
| cyclophosphamide | Drug | – |
| cyclosporine | Drug | – |
| cytarabine | Drug | – |
| idarubicin | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
- BackgroundPapadopoulos KP, Nichols G: Autologous peripheral blood progenitor (PBPC) transplantation in patients with chronic myeloid leukemia. Biol Blood Marrow Transplant 4(2): A-55, 109, 1998.
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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.
Gwen L. Nichols, MD study chair
Herbert Irving Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing filgrastim, recombinant interferon gamma and busulfan in people with Leukemia, run by Columbia University.
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: withdrawn, as of the sponsor's last update on 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
On the ClinicalTrials.gov record for NCT00002761, which also lists 1 linked publication.
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 19 Nov 2012.