LeukemiaPhase 1NCT00005946
Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
A Phase 1 study testing filgrastim, therapeutic allogeneic lymphocytes and cyclophosphamide in people with Leukemia and Lymphoma, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. White blood cells from donors may be able to prevent graft-versus-host disease in patients with hematologic cancer that has relapsed following donor peripheral stem cell transplantation. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- filgrastim, therapeutic allogeneic lymphocytes and cyclophosphamide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Jun 2002
- Phase
- Phase 1
- 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory hematologic malignancy Acute leukemia Myelodysplasia Non-Hodgkin's lymphoma Hodgkin's disease Multiple myeloma Chronic lymphocytic leukemia Chronic myeloid leukemia Accelerated phase or blast crisis Chronic phase with failed prior donor lymphocyte infusion No active acute or extensive chronic graft versus host disease Prior allogeneic stem cell transplant (SCT) required At least 60 days since prior SCT Nonmyeloablative SCT allowed
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Greater than 4 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No severe psychiatric illness that may preclude informed consent Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 7 days since prior immunomodulatory medications (e.g., interferon or interleukin-2) Chemotherapy: Not specified Endocrine therapy: At least 7 days since prior steroids Radiotherapy: Not specified Surgery: Not specified Other: At least 7 days since prior immunosuppressives (e.g., cyclosporine, tacrolimus, or mycophenolate mofetil) No concurrent immunosuppressive medications for graft versus host disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
About this study
Official title: A Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion for Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. White blood cells from donors may be able to prevent graft-versus-host disease in patients with hematologic cancer that has relapsed following donor peripheral stem cell transplantation.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell infusion in treating patients who have relapsed hematologic cancer following donor peripheral stem cell transplantation.
Read the detailed description
OBJECTIVES: I. Determine the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease in patients with hematologic malignancies relapsed after allogeneic stem cell transplantation.
OUTLINE: This is a dose de-escalation study. Patients receive etoposide IV continuously on days 1-3; cyclophosphamide IV on day 8; donor lymphocyte infusion IV on day 10; and filgrastim (G-CSF) subcutaneously or IV beginning on day 10 and continuing until blood counts recover. Cohorts of 3-6 patients receive six de-escalating levels of chemotherapy until the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease (GVHD) is determined. The target dose level is defined as the level at which 2 of 6 patients develop GVHD, and the next lower dose level has no more than 1 patient experiencing GVHD. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter.
PROJECTED ACCRUAL: A total of 18-21 patients will be accrued over 2 years.
- Being tested
- filgrastim, therapeutic allogeneic lymphocytes, cyclophosphamide, etoposide
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, recurrent/refractory childhood Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hodgkin Disease, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
therapeutic allogeneic lymphocytesBiological
cyclophosphamideDrug
etoposideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2004 (estimated)
- Study startOct 2000
- Primary completionJun 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bijoyesh Mookerjee, MD, Study chair, Jefferson Medical College of Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005946
- Sponsor's protocol ID
- MSGCC-9951
- Other IDs
- CDR0000067863, NCI-V00-1588
- Status last verified
- Oct 2019
- First submitted
- 5 Jul 2000
- Last updated
- 17 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion for Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00005946
- Acronym / sponsor ID
- MSGCC-9951
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Oct 2000 (actual)
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 5 Mar 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 tumor cells from dividing so they stop growing or die. White blood cells from donors may be able to prevent graft-versus-host disease in patients with hematologic cancer that has relapsed following donor peripheral stem cell transplantation.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell infusion in treating patients who have relapsed hematologic cancer following donor peripheral stem cell transplantation.
Detailed description
OBJECTIVES: I. Determine the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease in patients with hematologic malignancies relapsed after allogeneic stem cell transplantation.
OUTLINE: This is a dose de-escalation study. Patients receive etoposide IV continuously on days 1-3; cyclophosphamide IV on day 8; donor lymphocyte infusion IV on day 10; and filgrastim (G-CSF) subcutaneously or IV beginning on day 10 and continuing until blood counts recover. Cohorts of 3-6 patients receive six de-escalating levels of chemotherapy until the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease (GVHD) is determined. The target dose level is defined as the level at which 2 of 6 patients develop GVHD, and the next lower dose level has no more than 1 patient experiencing GVHD. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter.
PROJECTED ACCRUAL: A total of 18-21 patients will be accrued over 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| filgrastim | Biological | – |
| therapeutic allogeneic lymphocytes | Biological | – |
| cyclophosphamide | Drug | – |
| etoposide | Drug | – |
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 17 Oct 2019.
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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.
Bijoyesh Mookerjee, MD study chair
Jefferson Medical College of Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing filgrastim, therapeutic allogeneic lymphocytes and cyclophosphamide in people with Leukemia and Lymphoma, run by University of Maryland, Baltimore 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 17 Oct 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
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 17 Oct 2019.