LeukemiaNCT00021151
Compassionate Use of Campath-1H in Treating Patients With Refractory Prolymphocytic Leukemia or Chronic Lymphocytic Leukemia
A study testing alemtuzumab in people with Leukemia, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Compassionate use refers to providing a drug to a patient on humanitarian grounds before the drug has received official approval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- alemtuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to May 2002
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Confirmed prolymphocytic leukemia (PLL) or chronic lymphocytic leukemia (CLL) PLL that has failed at least 1 prior regimen CLL that has failed prior fludarabine, defined as: No response Disease progression while receiving therapy OR Relapse within 6 months of completion of last dose
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (unless secondary to direct liver infiltration with CLL) Renal: Creatinine no greater than 2 times ULN Other: HIV negative No active infection No other severe concurrent disease No mental disorders No prior allergic reaction to rat or mouse-derived CDR-grafted humanized monoclonal antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAMPATH-1H Compassionate Treatment In Patients With PLL Who Have Failed At Least One Prior Regimen And CLL Patients Who Have Failed Fludarabine Therapy
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Compassionate use refers to providing a drug to a patient on humanitarian grounds before the drug has received official approval.
PURPOSE: Compassionate use of Campath-1H in treating patients who have refractory prolymphocytic leukemia or chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES: I. Expand access to Campath-1H for patients with refractory prolymphocytic leukemia or chronic lymphocytic leukemia.
OUTLINE: Patients receive Campath-1H IV over 2 hours on days 1, 3, and 5. Treatment repeats weekly for 4-12 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Not specified
- Conditions
- Leukemia
- Being tested
- alemtuzumab
- Keywords
- refractory chronic lymphocytic leukemia, prolymphocytic leukemia
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alemtuzumabBiological
| Study group | Role | What they receive |
|---|---|---|
| Alemtuzumab | Experimental | Not described Receives: Biological: alemtuzumab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2004 (estimated)
- Study startJan 2000
- Primary completionApr 2001
- Study completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Bernard J. Silver, MD, Study chair, University Hospitals Seidman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021151
- Sponsor's protocol ID
- ILEX1999
- Other IDs
- CWRU-ILEX-1999, ILEX-CAM511-A1, NCI-G01-1977
- Status last verified
- Jan 2014
- First submitted
- 11 Jul 2001
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, Albitar M, Brettman L, Santabarbara P, Wacker B, Rai KR. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002 May 15;99(10):3554-61. doi: 10.1182/blood.v99.10.3554.
PubMed 11986207
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMPATH-1H Compassionate Treatment In Patients With PLL Who Have Failed At Least One Prior Regimen And CLL Patients Who Have Failed Fludarabine Therapy
- ClinicalTrials.gov ID
- NCT00021151
- Acronym / sponsor ID
- ILEX1999
- Conditions
- Leukemia
- Keywords
- refractory chronic lymphocytic leukemia, prolymphocytic leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Genzyme, a Sanofi Company
- Study start
- Jan 2000
- Primary completion
- Apr 2001 (actual)
- Study completion
- May 2002 (actual)
- First posted
- 13 Apr 2004 (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: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Compassionate use refers to providing a drug to a patient on humanitarian grounds before the drug has received official approval.
PURPOSE: Compassionate use of Campath-1H in treating patients who have refractory prolymphocytic leukemia or chronic lymphocytic leukemia.
Detailed description
OBJECTIVES: I. Expand access to Campath-1H for patients with refractory prolymphocytic leukemia or chronic lymphocytic leukemia.
OUTLINE: Patients receive Campath-1H IV over 2 hours on days 1, 3, and 5. Treatment repeats weekly for 4-12 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Not specified
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alemtuzumab | Experimental | Biological: alemtuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| alemtuzumab | Biological | Alemtuzumab |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Results publication: PubMed 11986207Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, Albitar M, Brettman L, Santabarbara P, Wacker B, Rai KR. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002 May 15;99(10):3554-61. doi: 10.1182/blood.v99.10.3554.
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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.
Bernard J. Silver, MD study chair
University Hospitals Seidman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alemtuzumab in people with Leukemia, run by Case Comprehensive Cancer Center at 1 site in United States.
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: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT00021151, which also lists 1 linked publication.
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 Jan 2014.