|- candidate number||1401|
|- NTR Number||NTR228|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||HO37 |
|- Public Title||Early intensification by (un)related allogeneic or autologous stem cell transplantation in adult acute lymphoblastic leukemia. A phase II study.|
|- Scientific Title||Early intensification by (un)related allogeneic or autologous stem cell transplantation in adult acute lymphoblastic leukemia. A phase II study.|
|- ACRONYM||HOVON 37 ALL|
|- hypothesis||Patients who are in 1st CR after autologous transplantation, may be randomized between no further treatment (arm A) and maintenance chemotherapy (arm B). The hypothesis to be tested is that maintenance therapy will prolong disease free survival, calculated from the date of randomization.|
|- Healt Condition(s) or Problem(s) studied||Acute Lymphoblastic Leukemia |
|- Inclusion criteria||1. Age between 16 and 59 (inclusive) years;|
2. Previously untreated with chemotherapy;
3. ALL according to the FAB criteria and immunological marker analysis (B-precursor ALL, T-ALL and AUL);
4. WHO performance status grade 0, 1, 2 or 3;
5. Patient informed consent.
|- Exclusion criteria||1. B-ALL (= mature B-ALL);|
2. Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease;
3. Second malignant disease, except cervix carcinoma stage I and non-melanoma skin cancer;
4. Persisting renal insufficiency, creatinine more than 200 mmol/l;
5. Active uncontrolled infections;
6. HIV positivity on serological tests.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-1999|
|- planned closingdate||1-nov-2005|
|- Target number of participants||200|
|- Interventions||All patients will receive early intensification:|
- cycle 1: prednisone, vincristine, daunorubicin, aspariganse, MTX i.t.
- cycle 2: Cytarabine, Mitoxantrone, MTX i.t.
- cycle 3: Methotrexate, asparaginase, 6-MP, MTX i.t.
After intensification patients will receive either an allogeneic sibling stem cell transplantation, a matched unrelated donor stem cell transplantation or an autologous stem cell transplantation.
Patients who received an autologous stem cell transplantation will be randomized between:
- Arm A: no further treatment.
- Arm B: maintenance treatment with 6-MP and MTX.
|- Primary outcome||Response after each course of chemotherapy and date of CR.|
|- Secondary outcome||1. Disease-free survival (i.e. time from achievement of first CR to the date of relapse or death from any cause, whichever occurs first);|
2. Event-free survival (i.e., time from start of therapy to the date of no complete response, death or relapse whichever occurs first): this takes into consideration induction failures and toxic deaths. The time to failure of patients with induction failure is set at one day;
3. Overall survival will be measured from time of registration until death or last contact;
4. Toxicities and treatment related mortality.
|- Trial web site||http://www.hovon.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.W. Dekker|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.W. Dekker|
|- Sponsor/Initiator ||VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Erasmus Medical Center, Daniel den Hoed Cancer Center |
(Source(s) of Monetary or Material Support)
|Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)|
|- Brief summary||Study phase:|
1. To study prospectively the value of early intensification by allogeneic or autologous stem cell transplantation in ALL;
2. To study prospectively stem cell transplantation with a matched unrelated donor in high-risk ALL when no sibling donor is available;
3. To study the value of donor lymphocyte infusion (DLI) in high-risk ALL with a molecular or cytogenetic relapse after allogeneic stem cell transplantation or in high-risk ALL with persistent residual disease (molecular; cytogenetic);
4. To study the value of maintenance chemotherapy in ALL patients after autologous transplantation;
5. To study leukemic cell reduction by means of (semi-quantitative) molecular techniques during induction chemotherapy, after consolidation with stem cell transplantation, and during maintenance chemotherapy in patients receiving an autologous stem cell transplantation.
Patients with previously untreated, B-precursor ALL, T-ALL or AUL, age 16-59 years inclusive.
Prospective, multicenter, randomized.
|- Main changes (audit trail)|
|- RECORD||6-sep-2005 - 15-sep-2008|