LeukemiaPhase 3NCT00002771
Chemotherapy, Interferon, and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
A Phase 3 study testing recombinant interferon alfa, busulfan and cytarabine in people with Leukemia, run by German CML Study Group at 1 site in Germany.
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 bone marrow 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?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- recombinant interferon alfa, busulfan and cytarabine
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteGermany
- Study dates
- Jan 1995to not given
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Newly diagnosed chronic myelogenous leukemia in chronic phase
- Philadelphia chromosome- or bcr/abl-positive
- Cytogenetic negativity (analyzed separately) allowed if at least 1 of the following criteria is met:
- Malaise with decreased performance status
- Weight loss of more than 10% within the past 6 months
- Fever more than 38.5 C for 5 consecutive days
- Symptomatic splenomegaly
- Leukocyte count greater than 50,000/mm^3
- Platelet count greater than 1,000,000/mm^3
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- See Disease Characteristics
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other medical condition that would reduce life expectancy
- No other uncontrolled malignancy
- Not pregnant
- No other contraindication to study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior interferon
Chemotherapy:
- No prior cytotoxic therapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROSPECTIVE CONTROLLED STUDY FOR THE OPTIMIZATION OF THERAPY IN CHRONIC MYELOID LEUKEMIA (CML): MULTICENTRIC STUDY FOR THE EVALUATION OF INTERFERON ALPHA VS ALLOGENIC BM TRANSPLANTATION WITH CHEMOTHERAPY IN CML
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens or bone marrow transplantation in treating patients with chronic myelogenous leukemia.
Read the detailed description
OBJECTIVES:
- Compare the duration of chronic phase chronic myelogenous leukemia (CML) and survival of these patients treated with standard remission induction comprising hydroxyurea (HU) and interferon alfa (IFN-A), followed by allogeneic bone marrow transplantation and consolidation comprising HU and IFN-A vs cytarabine and idarubicin.
- Compare the frequency of hematologic and cytogenetic remission (including elimination of Philadelphia-positive and/or BCR/ABL-positive chromosome abnormalities), time to remission, and duration of remission in patients treated with these regimens.
- Correlate the quality of hematologic and cytogenetic remission with the survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the disease progression in patients treated with these regimens.
- Correlate the duration of chronic phase CML and survival with prognostic criteria and the significance of normal vs subnormal leukocyte counts in patients treated with these regimens.
- Compare the survival of patients without a suitable allogeneic bone marrow donor treated with autologous bone marrow transplantation as consolidation therapy vs consolidation and maintenance chemotherapy regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, eligibility for allogeneic bone marrow transplantation (Allo-BMT) (yes vs no), donor availability (sibling vs unrelated vs none), and risk status (high vs low).
Induction therapy
- Patients receive induction therapy comprising oral hydroxyurea (HU) until WBC falls below 10,000/mm^3 and interferon alfa (IFN-A) subcutaneously (SC) daily beginning after WBC reduction and continuing in order to maintain WBC between 2,000-4,000/mm^3 and platelet count greater than 50,000/mm^3. If WBC is 10,000/mm^3 or greater on IFN-A alone, then HU must be restarted. Patients with disease progression and no anti-IFN antibody also receive cytarabine (ARA-C) SC for 15 days a months. Patients who develop disease progression while receiving ARA-C and IFN-A are taken off study.
- Patients who are eligible for Allo-BMT, have a sibling donor, and are age 55 and under receive induction therapy for a maximum of 1 year and then proceed to regimen B. Patients who are eligible for Allo-BMT, have an unrelated donor, and are age 45 and under receive induction therapy for 12-18 months. Those patients with cytogenetic remission receive induction therapy for up to 2 years and then proceed to regimen B. Those patients without cytogenetic remission proceed directly to regimen B. Patients who are ineligible for Allo-BMT, but are eligible for autologous BMT (AuBMT) or peripheral blood stem cell transplantation (PBSCT) receive induction therapy for a maximum of 1 year and then proceed to regimen C. Patients who are ineligible for Allo-BMT and achieve hematologic complete remission (CR) within 3 months receive induction therapy for 18 months. Those patients with cytogenetic remission proceed directly to regimen A. Those patients without cytogenetic remission proceed to randomization on regimen B. Patients who are ineligible for Allo-BMT and fail to achieve hematologic CR within 9 months proceed to randomization on regimen B. All other patients who are ineligible for Allo-BMT receive induction therapy for 1 year. Those patients with cytogenetic remission proceed to regimen A. Those patients without cytogenetic remission proceed to randomization on regimen B.
Consolidation/maintenance therapy
- Patients are assigned to 1 of 3 regimens.
- Regimen A: Patients continue to receive IFN-A as in induction therapy in the absence of disease progression.
- Regimen B: Patients receive conditioning therapy comprising busulfan for 4 days and/or total body irradiation, followed by Allo-BMT. Patients are then randomized to 1 of 2 treatment arms.
- Arm I: Patients receive consolidation therapy comprising HU and IFN-A as in induction therapy.
- Arm II: Patients receive consolidation therapy comprising ARA-C SC every 12 hours on days 1-5 and idarubicin (IDA) IV on days 3 and 4 (and day 5 for patients with responding disease). Consolidation therapy continues every 2 months for a total of 3 courses. When blood counts recover, patients receive maintenance therapy comprising IFN-A and ARA-C (if needed) as in induction therapy.
- Regimen C: Patients receive IDA and ARA-C as in arm II. Patients then undergo AuBMT or PBSCT.
Patients are followed every 3-6 months for at least 4 years.
PROJECTED ACCRUAL: Approximately 750 patients will be accrued for this study within 5 years.
- Conditions
- Leukemia
- Being tested
- recombinant interferon alfa, busulfan, cytarabine, hydroxyurea, idarubicin
- Keywords
- chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive, Philadelphia chromosome negative chronic myelogenous leukemia, childhood chronic myelogenous leukemia
- 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.
recombinant interferon alfaBiological
busulfanDrug
cytarabineDrug
hydroxyureaDrug
idarubicinDrug
allogeneic bone marrow transplantationProcedure or surgery
autologous bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German CML Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Ruediger Hehlmann, MD, Study chair, III. Medizinische Klinik Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002771
- Sponsor's protocol ID
- GER-CML-3
- Other IDs
- CDR0000064743, EU-95042
- Status last verified
- Jul 2000
- First submitted
- 1 Nov 1999
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE CONTROLLED STUDY FOR THE OPTIMIZATION OF THERAPY IN CHRONIC MYELOID LEUKEMIA (CML): MULTICENTRIC STUDY FOR THE EVALUATION OF INTERFERON ALPHA VS ALLOGENIC BM TRANSPLANTATION WITH CHEMOTHERAPY IN CML
- ClinicalTrials.gov ID
- NCT00002771
- Acronym / sponsor ID
- GER-CML-3
- Conditions
- Leukemia
- Keywords
- chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive, Philadelphia chromosome negative chronic myelogenous leukemia, childhood chronic myelogenous leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- German CML Study GroupUniversity, hospital or other
- Study start
- Jan 1995
- First posted
- 27 Jan 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 bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens or bone marrow transplantation in treating patients with chronic myelogenous leukemia.
Detailed description
OBJECTIVES:
- Compare the duration of chronic phase chronic myelogenous leukemia (CML) and survival of these patients treated with standard remission induction comprising hydroxyurea (HU) and interferon alfa (IFN-A), followed by allogeneic bone marrow transplantation and consolidation comprising HU and IFN-A vs cytarabine and idarubicin.
- Compare the frequency of hematologic and cytogenetic remission (including elimination of Philadelphia-positive and/or BCR/ABL-positive chromosome abnormalities), time to remission, and duration of remission in patients treated with these regimens.
- Correlate the quality of hematologic and cytogenetic remission with the survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the disease progression in patients treated with these regimens.
- Correlate the duration of chronic phase CML and survival with prognostic criteria and the significance of normal vs subnormal leukocyte counts in patients treated with these regimens.
- Compare the survival of patients without a suitable allogeneic bone marrow donor treated with autologous bone marrow transplantation as consolidation therapy vs consolidation and maintenance chemotherapy regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, eligibility for allogeneic bone marrow transplantation (Allo-BMT) (yes vs no), donor availability (sibling vs unrelated vs none), and risk status (high vs low).
Induction therapy
- Patients receive induction therapy comprising oral hydroxyurea (HU) until WBC falls below 10,000/mm^3 and interferon alfa (IFN-A) subcutaneously (SC) daily beginning after WBC reduction and continuing in order to maintain WBC between 2,000-4,000/mm^3 and platelet count greater than 50,000/mm^3. If WBC is 10,000/mm^3 or greater on IFN-A alone, then HU must be restarted. Patients with disease progression and no anti-IFN antibody also receive cytarabine (ARA-C) SC for 15 days a months. Patients who develop disease progression while receiving ARA-C and IFN-A are taken off study.
- Patients who are eligible for Allo-BMT, have a sibling donor, and are age 55 and under receive induction therapy for a maximum of 1 year and then proceed to regimen B. Patients who are eligible for Allo-BMT, have an unrelated donor, and are age 45 and under receive induction therapy for 12-18 months. Those patients with cytogenetic remission receive induction therapy for up to 2 years and then proceed to regimen B. Those patients without cytogenetic remission proceed directly to regimen B. Patients who are ineligible for Allo-BMT, but are eligible for autologous BMT (AuBMT) or peripheral blood stem cell transplantation (PBSCT) receive induction therapy for a maximum of 1 year and then proceed to regimen C. Patients who are ineligible for Allo-BMT and achieve hematologic complete remission (CR) within 3 months receive induction therapy for 18 months. Those patients with cytogenetic remission proceed directly to regimen A. Those patients without cytogenetic remission proceed to randomization on regimen B. Patients who are ineligible for Allo-BMT and fail to achieve hematologic CR within 9 months proceed to randomization on regimen B. All other patients who are ineligible for Allo-BMT receive induction therapy for 1 year. Those patients with cytogenetic remission proceed to regimen A. Those patients without cytogenetic remission proceed to randomization on regimen B.
Consolidation/maintenance therapy
- Patients are assigned to 1 of 3 regimens.
- Regimen A: Patients continue to receive IFN-A as in induction therapy in the absence of disease progression.
- Regimen B: Patients receive conditioning therapy comprising busulfan for 4 days and/or total body irradiation, followed by Allo-BMT. Patients are then randomized to 1 of 2 treatment arms.
- Arm I: Patients receive consolidation therapy comprising HU and IFN-A as in induction therapy.
- Arm II: Patients receive consolidation therapy comprising ARA-C SC every 12 hours on days 1-5 and idarubicin (IDA) IV on days 3 and 4 (and day 5 for patients with responding disease). Consolidation therapy continues every 2 months for a total of 3 courses. When blood counts recover, patients receive maintenance therapy comprising IFN-A and ARA-C (if needed) as in induction therapy.
- Regimen C: Patients receive IDA and ARA-C as in arm II. Patients then undergo AuBMT or PBSCT.
Patients are followed every 3-6 months for at least 4 years.
PROJECTED ACCRUAL: Approximately 750 patients will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| busulfan | Drug | – |
| cytarabine | Drug | – |
| hydroxyurea | Drug | – |
| idarubicin | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
Ruediger Hehlmann, MD study chair
III. Medizinische Klinik Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing recombinant interferon alfa, busulfan and cytarabine in people with Leukemia, run by German CML Study Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2013. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 2 Aug 2013.