Early intensification by (un)-related allogeneic or autologous stem cell transplantation in adult Acute Lymphoblastic Leukaemia: a phase II study
| ISRCTN | ISRCTN77441569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77441569 |
| Secondary identifying numbers | HO37, NL191 (NTR228) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 26/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.W. Dekker
Scientific
Scientific
University Medical Center Utrecht
Department of Hematology, (G03.647)
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | 030 2507655 |
|---|---|
| a.w.dekker@azu.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Early intensification by (un)-related allogeneic or autologous stem cell transplantation in adult Acute Lymphoblastic Leukaemia: a phase II study |
| Study acronym | HOVON 37 ALL |
| Study objectives | Patients who are in first Complete Response (CR) after autologous transplantation, may be randomised 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 randomisation. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute Lymphoblastic Leukaemia (ALL) |
| Intervention | 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 randomised between: Arm A: no further treatment. Arm B: maintenance treatment with 6-MP and MTX. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Prednisone, vincristine, daunorubicin, aspariganse, methotrexate (MTX), cytarabine, mitoxantrone, mercaptopurine (6-MP) |
| Primary outcome measure | Response after each course of chemotherapy and date of CR. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/1999 |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Age between 16 and 59 (inclusive) years 2. Previously untreated with chemotherapy 3. Acute Lymphoblastic Leukaemia (ALL) according to the French-American-British (FAB) criteria and immunological marker analysis (B-precursor ALL, T-cell Acute Lymphoblastic Leukaemia [T-ALL] and Acute Undifferentiated Leukaemia [AUL]) 4. World Health Organisation (WHO) performance status grade zero, one, two or three 5. Patient gives informed consent |
| Key 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. Human Immunodeficiency Virus (HIV) positivity on serological tests |
| Date of first enrolment | 01/04/1999 |
| Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht,
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Research organisation
Research organisation
Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2693 |
|---|---|
| hdc@hovon.nl | |
| Website | http://www.hovon.nl/ |
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Research organisation
Koningin Wilhelmina Fonds (KWF) (The Netherlands)
No information available
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/06/2011 | 26/08/2021 | Yes | No | |
| Results article | 23/02/2021 | 26/08/2021 | Yes | No |
Editorial Notes
26/08/2021: Publication references added.
