Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Unknown status

CT.gov ID

NCT00002926

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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.

PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes	Drug: cytarabine Drug: etoposide Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation	Phase 3

Detailed Description

OBJECTIVES:

Assess the value of autologous peripheral stem cell transplantation versus high dose cytarabine (Ara-C) performed after a common induction and consolidation course in patients with poor prognosis myelodysplastic syndromes (MDS) or acute myelogenous leukemia secondary to MDS.
Compare the disease free survival and overall survival of patients who reached complete recovery according to the presence of an HLA-identical donor.
Monitor cytogenetic and clonal remission after intensive antileukemic therapy including stem cell transplantation.
Monitor residual disease and the hematopoietic clonal status of autologous peripheral blood stem cells mobilized after one consolidation course.
Assess recovery time of granulocyte and platelet counts following each treatment step.

OUTLINE: Induction treatment with idarubicin on days 1,3,5; Ara-C from days 1 through 10; etoposide on days 1 through 5. On day 28 there will be assessment of responses. If there is at least partial response, the cycle will repeat the induction course for another 28 days. There is peripheral blood stem cell collection and cryopreservation following family HLA-typing. If there is no HLA match, then those who remained in remission after these consolidation courses will be randomized to either peripheral blood stem cell transplantation or HiDAC treatment.

PROJECTED ACCRUAL: 80 patients will be entered per year.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration

Study Start Date :

Dec 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Pathological confirmation of one of the following:
Untreated refractory anemia with excess blasts (RAEB) in transformation
RAEB with greater than 10% blasts cells in the bone marrow
Other myelodysplastic syndromes
Profound cytopenias
Acute myelogenous leukemia (AML) supervening after overt myelodysplastic syndromes (MDS) of more than 6 months duration
No blast crisis of chronic myeloid leukemia
No leukemias supervening after other myeloproliferative disease
No leukemias supervening after overt MDS of less than 6 months duration
The following are allowed:
Secondary acute leukemias following Hodgkin's disease or other malignancies
Secondary leukemias following exposure to alkylating agents or radiation

PATIENT CHARACTERISTICS:

Age:

16-60

Performance status:

WHO 0-2

Hematopoietic:

If RAEB, blasts cells of greater than 10% in bone marrow
Neutrophil count less than 5,000 or Platelet count less than 200,000
Chronic myelomonocytic leukemia (CMML) with greater than 5% blasts cells in bone marrow, or CMML with neutrophil count greater than 160,000 or monocyte count greater than 2,600

Hepatic:

Bilirubin no greater than 1.5 times normal

Renal:

Creatinine no greater than 1.5 times normal

Cardiovascular:

No patients with severe heart failure requiring diuretics or an ejection fraction of less than 50%

Neurological:

No severe concomitant neurological disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No treatments within the past 4 weeks of:
Biological response modifiers AND/OR
Low dose Ara-C

Chemotherapy:

No prior intensive treatment for MDS or AML

Endocrine therapy:

Not specified

Radiotherapy:

No prior treatment for MDS or AML

Surgery:

Not specified

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Algemeen Ziekenhuis Middelheim	Antwerp	Belgium	2020
2	A.Z. St. Jan	Brugge	Belgium	8000
3	Institut Jules Bordet	Brussels	Belgium	1000
4	Hopital Universitaire Erasme	Brussels	Belgium	1070
5	Cliniques Universitaires Saint-Luc	Brussels	Belgium	1200
6	Universitair Ziekenhuis Antwerpen	Edegem	Belgium	B-2650
7	U.Z. Gasthuisberg	Leuven	Belgium	B-3000
8	Clinique Universitaire De Mont-Godinne	Mont-Godinne Yvoir	Belgium	5530
9	University Hospital Rebro	Zagreb	Croatia	10000
10	Institute of Hematology and Blood Transfusion	Prague	Czech Republic	128 20
11	Hopital Edouard Herriot	Lyon	France	69437
12	Centre Antoine Lacassagne	Nice	France	06189
13	Hotel Dieu de Paris	Paris	France	75181
14	Hopital Necker	Paris	France	75743
15	Universitaetsklinik Duesseldorf	Duesseldorf	Germany	D-40225
16	Universitaetsklinik und Strahlenklinik - Essen	Essen	Germany	D-45122
17	Medizinische Klinik und Poliklinik	Heidelberg	Germany	92093-0671
18	Klinikum Grosshadern	Munich (Muenchen)	Germany	D-81377
19	Eberhard Karls Universitaet	Tuebingen	Germany	D-72076
20	Ospedale San Eugenio	Rome	Italy	00144
21	Leyenburg Ziekenhuis	's-Gravenhage	Netherlands	2545 CH
22	Vrije Universiteit Medisch Centrum	Amsterdam	Netherlands	1001HV
23	Onze Lieve Vrouwe Gasthuis	Amsterdam	Netherlands	1091 HA
24	Academisch Medisch Centrum	Amsterdam	Netherlands	1105 AZ
25	Leiden University Medical Center	Leiden	Netherlands	2300 CA
26	Academisch Ziekenhuis Maastricht	Maastricht	Netherlands	6202 AZ
27	University Medical Center Nijmegen	Nijmegen	Netherlands	NL-6500 HB
28	University Hospital - Rotterdam Dijkzigt	Rotterdam	Netherlands	3000 CA
29	Erasmus Medical Center	Rotterdam	Netherlands	3075 EA
30	Sophia Ziekehuis	Zwolle	Netherlands	8000 GK
31	Sahlgrenska University Hospital	Gothenburg (Goteborg)	Sweden	S-413 45
32	University Hospital of Linkoping	Linkoping	Sweden	S-581 85
33	Orebro University Hospital	Orebro	Sweden	70185
34	Huddinge University Hospital	Stockholm	Sweden	SE-141 86
35	University Hospital	Basel	Switzerland	CH-4031
36	Ospedale San Giovanni	Bellinzona	Switzerland	CH-6500
37	Inselspital, Bern	Bern	Switzerland	CH-3010
38	Hopital Cantonal Universitaire de Geneva	Geneva	Switzerland	CH-1211
39	Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland	CH-1011
40	Kantonsspital - St. Gallen	St. Gallen	Switzerland	CH-9007