LeukemiaPhase 3NCT00002989
Combination Chemotherapy With or Without Idarubicin and Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome
A Phase 3 study testing busulfan, cyclophosphamide and idarubicin in people with Leukemia and Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 9 sites in 5 countries.
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 16 to 60 years
- Conditions the study is for
- Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- busulfan, cyclophosphamide and idarubicin
- Type of treatment
- Surgery or procedure
- How many people
- 207 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Mar 1997to 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), lymphocytic leukemia (LL) or myelodysplastic syndromes (MDS) with at least one of the following high risk criteria: T-cell depleted stem cells or autologous stem cells Second complete response (CR) Previous CNS involvement No CR First CR achieved more than 5 weeks after start of remission-induction therapy Poor prognostic cytogenetic features: t(9;22), t(8;14), t(11;14), 11q23 anomalies, -5/5q-anomalies, -7/7q-anomalies, +8, complex cytogenetics Postcytotoxic/secondary AML Chronic myelogenous leukemia (CML) with at least one of the following high risk criteria: T-cell depleted stem cells Not in first chronic phase Non-Hodgkin's lymphoma or multiple myeloma Autologous stem cells
PATIENT CHARACTERISTICS: Age: 16 to 60 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No severe heart failure requiring diuretics No ejection fraction of less than 50% Neurologic: No severe concurrent neurological or psychiatric disease Other: HIV negative No allogeneic stem cells from donors other than HLA identical sibling(s)
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
France3 sites
Hopital Edouard Herriot
Lyon, 69437
Hotel Dieu de Paris
Paris, 75181
Institut Gustave Roussy
Villejuif, F-94805
Italy2 sites
Ospedale San Eugenio
Rome, 00144
Azienda Policlinico Umberto Primo
Rome, 00161
Netherlands2 sites
Leiden University Medical Center
Leiden, 2300 CA
University Medical Center Nijmegen
Nijmegen, NL-6500 HB
About this study
Official title: A Randomized Phase III Study to Assess Intensification of the Conditioning Regimen for Allogenic Stem Cell Transplantation (ALLO-SCT) for Leukemia or Myelodysplastic Syndrome With a High Risk of Relapse
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: Randomized phase III trial to compare the effectiveness of idarubicin plus peripheral stem cell transplantation using the patient's own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome.
Read the detailed description
OBJECTIVES: I. Assess the value of idarubicin added to the standard conditioning regimen of allogeneic and autologous stem cell transplantation in patients with leukemia or myelodysplastic syndrome at high risk of relapse. II. Determine time to recovery of polymorphonuclear neutrophil leukocyte (PMN) and platelet counts in these patients. III. Evaluate the rate and type of grade 3-4 toxicity, particularly mucositis, and the number of days with fever in these patients. IV. Determine the incidence of acute and chronic graft versus host disease (GVHD) in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease (acute myelogenous leukemia (AML) vs acute lymphocytic leukemia (ALL) or lymphoblastic leukemia (LL) vs myelodysplastic syndrome (MDS) or secondary AML vs chronic myelogenous leukemia (CML) vs non-Hodgkin's lymphoma vs multiple myeloma), stage of disease (if not CML, 1st complete response (CR) vs 2nd CR vs no 1st/2nd CR; if CML, 1st CR vs other phases), conditioning regimen (cyclophosphamide (CTX) and total body irradiation (TBI) vs busulfan (BU) and CTX vs other), source of donor (allogeneic vs autologous), T-cell depletion or autologous transplantation (no vs yes), and source of stem cells (bone marrow vs peripheral blood stem cell). Patients are randomized to receive a standard regimen or an intensified regimen. Standard pretransplant treatment: CTX on days -6 and -5 and TBI on days -4 through -2, or BU on days -8 through -5 and CTX on days -4 and -3, or BU on days -8 through -5 and melphalan IV on day -4. Intensified pretransplant regimens: I. Continuous infusion of idarubicin (IDA) over 48 hours on days -12 and -11, followed 5 days later with CTX on days -6 and -5 and TBI on days -4 to -2 II. IDA followed 5 days later with BU on days -8 through -5, and then CTX on days -4 and -3 III. IDA followed by BU on days -8 through -5 and melphalan IV on day -4. Stem cells are infused on day 0. Patients are followed every 3 months during the first 3 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 207 patients will be accrued for this study within 3 years.
- Being tested
- busulfan, cyclophosphamide, idarubicin, melphalan, radiation therapy
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
busulfanDrug
cyclophosphamideDrug
idarubicinDrug
melphalanDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2003 (estimated)
- Study startMar 1997
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.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Investigators
- Theo De Witte, MD, PhD, Study chair, Universitair Medisch Centrum St. Radboud - Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002989
- Sponsor's protocol ID
- CDR0000065526
- Other IDs
- EORTC-06962
- Status last verified
- Jul 2007
- First submitted
- 1 Nov 1999
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study to Assess Intensification of the Conditioning Regimen for Allogenic Stem Cell Transplantation (ALLO-SCT) for Leukemia or Myelodysplastic Syndrome With a High Risk of Relapse
- ClinicalTrials.gov ID
- NCT00002989
- Acronym / sponsor ID
- CDR0000065526
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, adult acute myeloid leukemia in remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Mar 1997
- First posted
- 25 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: Randomized phase III trial to compare the effectiveness of idarubicin plus peripheral stem cell transplantation using the patient's own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome.
Detailed description
OBJECTIVES: I. Assess the value of idarubicin added to the standard conditioning regimen of allogeneic and autologous stem cell transplantation in patients with leukemia or myelodysplastic syndrome at high risk of relapse. II. Determine time to recovery of polymorphonuclear neutrophil leukocyte (PMN) and platelet counts in these patients. III. Evaluate the rate and type of grade 3-4 toxicity, particularly mucositis, and the number of days with fever in these patients. IV. Determine the incidence of acute and chronic graft versus host disease (GVHD) in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease (acute myelogenous leukemia (AML) vs acute lymphocytic leukemia (ALL) or lymphoblastic leukemia (LL) vs myelodysplastic syndrome (MDS) or secondary AML vs chronic myelogenous leukemia (CML) vs non-Hodgkin's lymphoma vs multiple myeloma), stage of disease (if not CML, 1st complete response (CR) vs 2nd CR vs no 1st/2nd CR; if CML, 1st CR vs other phases), conditioning regimen (cyclophosphamide (CTX) and total body irradiation (TBI) vs busulfan (BU) and CTX vs other), source of donor (allogeneic vs autologous), T-cell depletion or autologous transplantation (no vs yes), and source of stem cells (bone marrow vs peripheral blood stem cell). Patients are randomized to receive a standard regimen or an intensified regimen. Standard pretransplant treatment: CTX on days -6 and -5 and TBI on days -4 through -2, or BU on days -8 through -5 and CTX on days -4 and -3, or BU on days -8 through -5 and melphalan IV on day -4. Intensified pretransplant regimens: I. Continuous infusion of idarubicin (IDA) over 48 hours on days -12 and -11, followed 5 days later with CTX on days -6 and -5 and TBI on days -4 to -2 II. IDA followed 5 days later with BU on days -8 through -5, and then CTX on days -4 and -3 III. IDA followed by BU on days -8 through -5 and melphalan IV on day -4. Stem cells are infused on day 0. Patients are followed every 3 months during the first 3 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 207 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| busulfan | Drug | – |
| cyclophosphamide | Drug | – |
| idarubicin | Drug | – |
| melphalan | Drug | – |
| 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 9 Feb 2009.
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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.
Theo De Witte, MD, PhD study chair
Universitair Medisch Centrum St. Radboud - Nijmegen
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing busulfan, cyclophosphamide and idarubicin in people with Leukemia and Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 9 sites in 5 countries.
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: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Italy, Netherlands, Belgium, 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 9 Feb 2009.