LeukemiaPhase 2NCT00005829
Gemcitabine in Treating Patients With Recurrent Chronic Lymphocytic Leukemia
A Phase 2 study testing gemcitabine hydrochloride in people with Leukemia, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- gemcitabine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Apr 2008
- Phase
- Phase 2
- 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: Diagnosis of B-cell chronic lymphocytic leukemia manifested by all of the following: Minimum threshold peripheral lymphocyte count of at least 5,000/mm3 Small to medium sized peripheral blood lymphocytes with no greater than 55% prolymphocytes Bone marrow aspirate and biopsy containing at least 30% lymphoid cells Immunophenotypic and biopsy evaluation of peripheral blood lymphocytes demonstrating monoclonality of B lymphocytes B-cell markers with CD5 antigen (e.g., T-1, T-101) in the absence of other pan T-cell markers (e.g., CD3, CD2) Expression of CD19, CD20, and CD23 B cell surface markers B-cell expression of kappa or lambda light chains Active disease with at least one of the following criteria: One or more disease related symptoms: At least 10% weight loss within the past 6 months Fever greater than 100.5 F for at least 2 weeks without evidence of infection Night sweats without evidence of infection Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin less than 11.0 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm3) (i.e., any stage III or IV disease) Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy Massive (i.e., greater than 6 cm below the left costal margin) or progressive splenomegaly (i.e., a greater than 50% increase over two months) Massive (i.e., greater than 10 cm in longest diameter) or progressive lymphadenopathy (i.e., a greater than 50% increase over two months) Progressive lymphocytosis with an increase of greater than 50% over a 2 month period (unrelated to corticosteroids) or an anticipated doubling time of less than 6 months No marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any criteria for active disease Previously treated with at least a fludarabine or cladribine based regimen and a prior alkylating agent with evidence of recurrent or progressive disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN (unless due to hemolysis or chronic lymphocytic leukemia) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial infarction within the past month Other: No uncontrolled infection HIV negative No other active malignancy 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 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery
About this study
Official title: Phase II Study of Gemcitabine for Relapsed B-Cell Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES: I. Determine the rate and duration of complete and partial remission in patients with recurrent B-cell chronic lymphocytic leukemia treated with gemcitabine. II. Assess the toxicities of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 4 weeks for a minimum of 3 courses. Patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. Patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. Patients are followed every 3 months until disease progression or relapse. Patients achieving complete remission are followed every 6 months for 1 year.
- Conditions
- Leukemia
- Being tested
- gemcitabine hydrochloride
- Keywords
- refractory chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine | Experimental | Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 4 weeks for a minimum of 3 courses. Patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. Patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. Patients are followed every 3 months until disease progression or relapse. Patients achieving complete remission are followed every 6 months for 1 year. Receives: Drug: gemcitabine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
confirmed response
Measured: Up to 20 weeks
Secondary outcomes (3)
overall survival
Measured: Up to 8 years
progression free survival
Measured: Up to 8 years
time to progression
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2004 (estimated)
- Study startFeb 2000
- Primary completionOct 2002
- Study completionApr 2008
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 Alliance for Clinical Trials in OncologyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Timothy G. Call, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005829
- Sponsor's protocol ID
- NCCTG-98-81-52
- Other IDs
- NCCTG-988152, CDR0000067843, NCI-2012-02331
- Status last verified
- Dec 2016
- First submitted
- 2 Jun 2000
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Call TG, Constantinou CL, Kahanic SP, et al.: NCCTG trial of gemcitabine for relapsed B-cell chronic lymphocytic leukemia. [Abstract] J Clin Oncol 22 (Suppl 14): A-6726, 613s, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine for Relapsed B-Cell Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00005829
- Acronym / sponsor ID
- NCCTG-98-81-52
- Conditions
- Leukemia
- Keywords
- refractory chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Primary completion
- Oct 2002 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Jun 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia.
Detailed description
OBJECTIVES: I. Determine the rate and duration of complete and partial remission in patients with recurrent B-cell chronic lymphocytic leukemia treated with gemcitabine. II. Assess the toxicities of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 4 weeks for a minimum of 3 courses. Patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. Patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. Patients are followed every 3 months until disease progression or relapse. Patients achieving complete remission are followed every 6 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine | Experimental | Drug: gemcitabine hydrochloridePatients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 4 weeks for a minimum of 3 courses. Patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. Patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. Patients are followed every 3 months until disease progression or relapse. Patients achieving complete remission are followed every 6 months for 1 year. |
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 |
|---|---|---|
| gemcitabine hydrochloride | Drug | gemcitabine |
Primary outcome
confirmed response
Time frame: Up to 20 weeks
3 secondary outcomes
overall survival
Time frame: Up to 8 years
progression free survival
Time frame: Up to 8 years
time to progression
Time frame: Up to 8 years
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 7 Dec 2016.
- Results publicationCall TG, Constantinou CL, Kahanic SP, et al.: NCCTG trial of gemcitabine for relapsed B-cell chronic lymphocytic leukemia. [Abstract] J Clin Oncol 22 (Suppl 14): A-6726, 613s, 2004.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Timothy G. Call, MD study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine hydrochloride in people with Leukemia, run by Alliance for Clinical Trials in Oncology.
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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
confirmed response (time frame: Up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005829, 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 7 Dec 2016.