LymphomaPhase 1/2NCT00562978
Yttrium Y 90 Ibritumomab Tiuxetan, Etoposide, Cyclophosphamide, and an AHSCT in Non-Hodgkin's Lymphoma Patients
A Phase 1/2 study testing filgrastim, cyclophosphamide and etoposide in people with Lymphoma, run by City of Hope Medical Center.
Trial summary
RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry tumor-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, cyclophosphamide and etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2000to 21 May 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Biopsy proven diagnosis of low- or intermediate-grade* non-Hodgkin lymphoma (NHL) including any of the following:
- Follicular small cleaved
- Follicular mixed
- Follicular large cell
- Diffuse small cleaved
- Diffuse mixed
- Diffuse large cell
- Immunoblastic (working formulation B, C, D, E, F, G and H) NOTE: *A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low-", "intermediate-", or "high-" grade lymphoma. However, this protocol uses the former terminology.
- Mantle cell and transformed low-grade lymphomas allowed
- Demonstrated monoclonal CD20-positive B-cell population in lymph nodes and/or bone marrow
- Favorable biodistribution on imaging dose
- Patient either relapsed after achieving a complete (CR) or partial response (PR) to prior therapy, never responded to prior therapy, or has poor-risk disease
- Sensitivity of disease based on 1 of the following:
- Induction failure: patients who did not achieve a CR or PR from induction chemotherapy
- Resistant relapse: patients who did not achieve a CR or PR from the most recent standard salvage chemotherapy
- Sensitive relapse: patients who did achieve a CR or PR from the most recent standard salvage chemotherapy
- Poor-risk disease defined as any of the following:
- Age-adjusted International Prognostic Index (IPI) High- (3 risk factors) or High-Intermediate (2 risk factors) based on the following risk factors:
- Stage III-IV disease
- Elevated serum lactate dehydrogenase level
- ECOG performance status 2-4
- Patients with aggressive NHL including mantle cell lymphoma and who required 2 different induction chemotherapy regimens to achieve a CR/PR
- Patients with B-cell NHL and who failed to achieve a CR after adequate induction chemotherapy regimen(s)
- Patients must have bone marrow aspiration and biopsy within 42 days before salvage chemotherapy or stem cell collection which show ≤ 10% lymphomatous involvement of total cellularity
- Normal cytogenetic study on bone marrow (prior to salvage chemotherapy or stem cell collection)
- Cytogenetic study on peripheral blood is acceptable if bone marrow biopsy has already been done and shows no sign of myelodysplastic syndrome (MDS) or lymphoma and a repeat bone marrow is deemed unnecessary by attending physician
- No active or prior history of CNS diseases
- No human anti-mouse antibody (HAMA) or human anti-chimeric antibody
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 or Karnofsky PS 80-100%
- Platelet count normal
- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min
- FEV_1 > 65% of predicted or DLCO ≥ 50% of predicted
- LVEF > 50% by ECHO or MUGA scan
- Bilirubin ≤ 1.5 times normal
- SGOT or SGPT ≤ 2 times normal
- HIV antibody-negative
- No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma, or other cancer from which the patient has been disease-free for at least five years
- No active evidence of hepatitis B or C infection
- No hepatitis B surface antigen positivity
- No history of alcohol abuse
- Body weight ≤ 250 pounds
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Patients who have received involved field external beam therapy to area excluding lung, heart, liver and kidney are allowed, but will be evaluated on a case-by-case basis
- Patients must have recovered from last therapy and should be at least four weeks from prior radiation or chemotherapy
- No prior radioimmunotherapy
- No prior bone marrow transplantation
About this study
Official title: A Phase I/II Trial of Escalating Dose of Yttrium-90-labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Etoposide and Cyclophosphamide Followed by AHSCT for Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma
RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Giving radiolabeled monoclonal antibodies together with etoposide and cyclophosphamide before a peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with etoposide and cyclophosphamide followed by an autologous stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
- To evaluate the safety and efficacy of a new preparative regimen of yttrium Y 90 ibritumomab tiuxetan in combination with high-dose etoposide and cyclophosphamide followed by autologous stem cell transplantation (ASCT) for treatment of patients with poor-risk, relapsed, or refractory non-Hodgkin lymphoma (NHL).
- To determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan which can be given with high-dose etoposide and high-dose cyclophosphamide followed by ASCT in patients with NHL.
- To perform dosimetry study to estimate the radiation dose delivered to the tumor and normal organs.
- To evaluate the short-term and long-term complications of this new preparative regimen.
OUTLINE: This is a phase I does-escalation study of yttrium Y 90 ibritumomab tiuxetan followed by an open-label phase II study.
- Preparation for transplantation: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy.
- Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan IV on days -21 and -14. Patients undergo bone marrow biopsy and dose estimation on day -7.
- Chemotherapy: Patients receive etoposide IV on day -4 and cyclophosphamide IV over 2 hours on day -2.
- Transplantation: Patients undergo reinfusion of PBSCs on day 1.
- Growth factor therapy: Patients receive filgrastim (G-CSF) IV beginning on day 1 and continuing until blood counts recover.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
- Conditions
- Lymphoma
- Being tested
- filgrastim, cyclophosphamide, etoposide, AHSCT, yttrium Y 90 ibritumomab tiuxetan
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent mantle cell lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
cyclophosphamideDrug
Also called Cytoxan
etoposideDrug
Also called VP-16
AHSCTProcedure or surgery
Also called autologous hematopoietic stem cell transplantation
yttrium Y 90 ibritumomab tiuxetanRadiation
Also called Zevalin
| Study group | Role | What they receive |
|---|---|---|
| Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg | Experimental | * Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy.
* Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation.
* Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV
* AHSCT: Patients undergo reinfusion of PBSCs.
* Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: etoposide; Procedure: AHSCT; Radiation: yttrium Y 90 ibritumomab tiuxetan |
| Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg | Experimental | * Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy.
* Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation.
* Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV
* AHSCT: Patients undergo reinfusion of PBSCs.
* Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: etoposide; Procedure: AHSCT; Radiation: yttrium Y 90 ibritumomab tiuxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Achieving Complete Response (CR)
Complete response is defined as complete disappearance of all measureable evidence of non-evaluable disease. No new lesions. No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. All measureable, evaluable and non-evaluable lesions and sites must be assessed using the same techniques as baseline.
Measured: Assessed up to 5 years post-ASCT
Number of Patients With Grade 3 or Greater Toxicity
The NCI Common Toxicity Criteria (CTC Version 2.0) are used. The patients, whose toxicities are grade 3 or greater and at possibly related to the study treatment, are reported.
Measured: From initial of study treatment to Day 100 post-ASCT
5-Year Overall Survival (Phase II)
Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]
Measured: From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years
5-Year Disease-free Survival (Phase II)
Disease-free survival (DFS) was defined as time from peripheral stem cell infusion to relapse or death. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Disease-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]
Measured: From peripheral stem cell infusion (Day0 ASCT) to first observation of relapse or death due to any cause, whichever comes first, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study start16 May 2000
- Primary completion21 May 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Auayporn P. Nademanee, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562978
- Sponsor's protocol ID
- 98153
- Other IDs
- P30CA033572, P01CA030206, CHNMC-98153, CDR0000574716
- Status last verified
- Feb 2021
- First submitted
- 22 Nov 2007
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Escalating Dose of Yttrium-90-labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Etoposide and Cyclophosphamide Followed by AHSCT for Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00562978
- Acronym / sponsor ID
- 98153
- Conditions
- Lymphoma
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent mantle cell lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 May 2000 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Giving radiolabeled monoclonal antibodies together with etoposide and cyclophosphamide before a peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with etoposide and cyclophosphamide followed by an autologous stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.
Detailed description
OBJECTIVES:
- To evaluate the safety and efficacy of a new preparative regimen of yttrium Y 90 ibritumomab tiuxetan in combination with high-dose etoposide and cyclophosphamide followed by autologous stem cell transplantation (ASCT) for treatment of patients with poor-risk, relapsed, or refractory non-Hodgkin lymphoma (NHL).
- To determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan which can be given with high-dose etoposide and high-dose cyclophosphamide followed by ASCT in patients with NHL.
- To perform dosimetry study to estimate the radiation dose delivered to the tumor and normal organs.
- To evaluate the short-term and long-term complications of this new preparative regimen.
OUTLINE: This is a phase I does-escalation study of yttrium Y 90 ibritumomab tiuxetan followed by an open-label phase II study.
- Preparation for transplantation: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy.
- Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan IV on days -21 and -14. Patients undergo bone marrow biopsy and dose estimation on day -7.
- Chemotherapy: Patients receive etoposide IV on day -4 and cyclophosphamide IV over 2 hours on day -2.
- Transplantation: Patients undergo reinfusion of PBSCs on day 1.
- Growth factor therapy: Patients receive filgrastim (G-CSF) IV beginning on day 1 and continuing until blood counts recover.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg | Experimental | Biological: filgrastim, Drug: cyclophosphamide, Drug: etoposide, Procedure: AHSCT, Radiation: yttrium Y 90 ibritumomab tiuxetan* Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation. * Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV * AHSCT: Patients undergo reinfusion of PBSCs. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. |
| Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg | Experimental | Biological: filgrastim, Drug: cyclophosphamide, Drug: etoposide, Procedure: AHSCT, Radiation: yttrium Y 90 ibritumomab tiuxetan* Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation. * Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV * AHSCT: Patients undergo reinfusion of PBSCs. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 | Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg, Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg |
| cyclophosphamideAlso: Cytoxan | Drug | Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg, Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg |
| etoposideAlso: VP-16 | Drug | Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg, Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg |
| AHSCTAlso: autologous hematopoietic stem cell transplantation | Procedure or surgery | Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg, Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg |
| yttrium Y 90 ibritumomab tiuxetanAlso: Zevalin | Radiation | Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg, Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg |
Primary outcome
Number of Patients Achieving Complete Response (CR)
Time frame: Assessed up to 5 years post-ASCT
Complete response is defined as complete disappearance of all measureable evidence of non-evaluable disease. No new lesions. No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. All measureable, evaluable and non-evaluable lesions and sites must be assessed using the same techniques as baseline.
Number of Patients With Grade 3 or Greater Toxicity
Time frame: From initial of study treatment to Day 100 post-ASCT
The NCI Common Toxicity Criteria (CTC Version 2.0) are used. The patients, whose toxicities are grade 3 or greater and at possibly related to the study treatment, are reported.
5-Year Overall Survival (Phase II)
Time frame: From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years
Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]
5-Year Disease-free Survival (Phase II)
Time frame: From peripheral stem cell infusion (Day0 ASCT) to first observation of relapse or death due to any cause, whichever comes first, assessed up to 5 years
Disease-free survival (DFS) was defined as time from peripheral stem cell infusion to relapse or death. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Disease-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Auayporn P. Nademanee, MD study chair
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing filgrastim, cyclophosphamide and etoposide in people with Lymphoma, run by City of Hope Medical Center.
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 18 Jun 2021. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Achieving Complete Response (CR) (time frame: Assessed up to 5 years post-ASCT). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Jun 2021.