Alemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse: a randomized phase II study
| ISRCTN | ISRCTN86445183 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86445183 |
| Secondary identifying numbers | HO74 |
- Submission date
- 07/06/2006
- Registration date
- 07/06/2006
- Last edited
- 07/06/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof R. Willemze
Scientific
Scientific
Leiden University Medical Center (LUMC)
Department of Hematology C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262267 |
|---|---|
| rwillemze@lumc.nl |
Study information
| Study design | Randomized, phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HOVON 74 ALL |
| Study objectives | The hypothesis to be tested is that arm A and/or arm B are feasible. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute lymphoblastic leukemia (ALL) |
| Intervention | Relapsed ALL patients under the age of 71 years will be registered and randomized to receive: Arm A: prednisone and methotrexate in the pre-phase and thereafter two remission induction courses of alemtuzumab 30 mg Arm B: prednisone and methotrexate in the pre-phase and thereafter two remission induction courses of alemtuzumab 60 mg |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Alemtuzumab, prednisone and methotrexate |
| Primary outcome measure | 1. Percentage of patients that reach a complete remission (CR) on induction cycle I in each arm 2. Percentage of patients with severe toxicity on induction cycle I in each arm |
| Secondary outcome measures | 1. Toxicity profile related to each treatment step and intervals between treatment steps 2. Event-free survival (i.e. time from registration until no CR on protocol, relapse or death, whichever comes first). Event-free survival for patients without a CR is set at one day. 3. Disease-free survival (i.e. time from achievement of CR to date of relapse or death from any cause, whichever occurs first) 4. Overall survival measured from time of registration |
| Overall study start date | 15/05/2006 |
| Completion date | 15/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Age 18 - 70 years inclusive 2. First or second relapse of precursor B-cell ALL (B-ALL) or T-cell (T-ALL) (including Philadelphia chromosome or BCR-ABL tyrosine kinase positive ALL) 3. Duration of last complete remission at least 6 months 4. World Health Organization (WHO) performance status 0, 1, or 2 5. Negative pregnancy test at inclusion if applicable 6. Written informed consent |
| Key exclusion criteria | 1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma 2. Acute undifferentiated leukemia (AUL) 3. Treatment with alemtuzumab at any time prior to registration 4. Intolerance of exogenous protein administration 5. Central nervous system (CNS) leukemia 6. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease) 7. Severe pulmonary dysfunction (Common Terminology Criteria for Adverse Events [CTCAE] grade III-IV) 8. Severe neurological or psychiatric disease 9. Significant hepatic dysfunction (serum bilirubin or transaminases >/= 3 times normal level) 10. Significant renal dysfunction (serum creatinine >/= 3 times normal level) 11. Patients with active, uncontrolled infections 12. Patients with uncontrolled asthma or allergy, requiring oral steroid treatment at the time of registration 13. Patients known to be human immunodeficiency virus (HIV)-positive 14. Patient is a lactating woman 15. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule |
| Date of first enrolment | 15/05/2006 |
| Date of final enrolment | 15/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
Research organisation
Research organisation
HOVON Data Center
Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 4391568 |
|---|---|
| hdc@erasmusmc.nl | |
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Industry
Dutch Cancer Society
No information available
Johnson and Johnson-Orthobiotech
No information available
Schering International
No information available
Novartis Pharma B.V.
No information available
Amgen
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amgen Inc., Applied Molecular Genetics Inc.
- Location
- United States of America
Roche Nederland BV
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 |
