Cyclophosphamide for Relapse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, CA
Relapse+22 More
Cyclophosphamide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a new type of cell therapy may help treat patients with lymphoma or leukemia.

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Eligible Conditions

  • Relapse
  • CD19 Positive
  • Recurrent Small Lymphocytic Lymphoma
  • chronic, recurrent Lymphocytic Leukemia
  • Refractory Mantle Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • CD20 Positive
  • Refractory Small Lymphocytic Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Refractory Diffuse Large B Cell Lymphoma (DLBCL)
  • Refractory Follicular Lymphoma
  • Chronic Lymphocytic Leukemia (CLL) - Refractory
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Relapse

Study Objectives

This trial is evaluating whether Cyclophosphamide will improve 2 primary outcomes, 8 secondary outcomes, and 1 other outcome in patients with Relapse. Measurement will happen over the course of Up to 28 days from infusion.

Year 15
Overall survival (OS)
Year 15
Progression-free survival
Year 15
Duration of remission
Up to 15 years
Clinical response
Objective response rate (ORR)
Year 2
Duration of B-cell aplasia following CART19/20 infusion.
Day 28
Dose-limiting toxicities
Incidence of adverse events
Day 30
Analysis of proteins/cytokines (c-reactive protein (CRP), interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ)) concentration in peripheral blood following CART19/20 infusion.
Year 5
Chimeric antigen receptor (CAR) T-cell (T) 19/20 bispecific transgenic T-cell persistence
Frequency of T cell phenotypic markers on CART19/20 cells using flow cytometry

Trial Safety

Safety Progress

1 of 3

Other trials for Relapse

Trial Design

1 Treatment Group

Treatment (fludarabine, cyclophosphamide, CD19/CD20 T-cells)
1 of 1
Experimental Treatment

This trial requires 24 total participants across 1 different treatment group

This trial involves a single treatment. Cyclophosphamide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment (fludarabine, cyclophosphamide, CD19/CD20 T-cells)CONDITIONING CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 60 minutes 5, 4, and 3 days before cell infusion. T-CELL INFUSION: Patients receive CD19/CD20 CAR-T cells IV on day 0. Patients with cytokine release syndrome may also receive tocilizumab IV on day 2 at the discretion of the clinical investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Tocilizumab
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 years for reporting.

Closest Location

UCLA / Jonsson Comprehensive Cancer Center - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Relapse or one of the other 22 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL) that is refractory to standard-of-care options
DLBCL and PMBCL: primary refractory; relapsed after two prior lines of therapy
MCL, FL, CLL, and SLL: primary refractory; relapsed after three or more prior rounds of therapy
> 30% positivity in malignant cells of either CD19 and/or CD20
Minimum tumor burden of 1.5 cm^3 for lymphoma
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate bone marrow and major organ function to undergo a T cell transplant determined within 30?60 days prior to enrollment using standard phase I criteria for organ function. Blood may be evaluated while a patient is receiving growth factor support. Patients will be re-evaluated for organ function within 14 days of beginning conditioning chemotherapy
Absolute neutrophil count (ANC) >= 1 x 10^9 cells/L (within 30-60 days prior to enrollment)
Platelets >= 75 x 10^9/L (within 30-60 days prior to enrollment)
Hemoglobin >= 8 g/dL (with or without transfusion) (within 30-60 days prior to enrollment)

Patient Q&A Section

What is leukemia, lymphocytic, chronic, b-cell?

"A diagnosis of [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) or chronic myeloid leukemia is a serious health issue that can cause serious problems when present in the early part of the disease. The most frequent types of chronic lymphocytic leukemia or chronic myeloid leukemia are B cell chronic lymphocytic leukemia or chronic myeloid leukemia (CLL/CML); CLL/CML." - Anonymous Online Contributor

Unverified Answer

What causes leukemia, lymphocytic, chronic, b-cell?

"The cause of leukemia is not clear, but researchers believe it may be a combination of genetic, environmental, diet, and other influences. In particular, researchers believe that certain environmental exposures, such as exposure to radiation, may increase leukemia risk.\n" - Anonymous Online Contributor

Unverified Answer

How many people get leukemia, lymphocytic, chronic, b-cell a year in the United States?

"Because current data suggest that a growing number of people will develop cancer over time, our focus will continue to be on developing a general definition of cancer in this population and developing tools that help clinicians plan care to be optimized." - Anonymous Online Contributor

Unverified Answer

Can leukemia, lymphocytic, chronic, b-cell be cured?

"Findings from a recent study suggest that a complete remission (CR) can be achieved in some patients with B chronic lymphocytic leukemia (CLL) using an intense consolidation chemotherapy for 6 or longer treatments with the aim of cure." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia, lymphocytic, chronic, b-cell?

"There is little evidence of clinical efficacy for any of the treatment modalities analyzed. Most of the trials were single-agent, short-lived therapies (i.e., <3 months) that had disappointing results. Further study is needed to determine if these results generalize to most leukemia patients, and if other treatment modalities would be better alternatives for longer-term, disease-free treatment." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia, lymphocytic, chronic, b-cell?

"Signs of leukemia manifest as lightheadedness, feeling unwell, loss of vigor, and a change in appetite. Other signs may include swollen lymph nodes (usually under the collar-bones), weight loss due to anaemia, or low red blood cell count. Many cases of chronic fatigue syndrome (CFS) have a sudden onset of severe, often debilitating symptoms, which sometimes include nausea, aching and weakness, and the symptoms can be severe, and they can lead to a diagnosis of CFS. A diagnosis of Lyme disease requires the presence of erythema migrans rash, fatigue, and/or a positive ELISA test for infection. The latter must be carried out by an experienced laboratory." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets leukemia, lymphocytic, chronic, b-cell?

"<nowiki>http://www.nhlbi.nih.gov/prog[ra](https://www.withpower.com/clinical-trials/ra)ms/leucoma/[leukemia](https://www.withpower.com/clinical-trials/leukemia).html</nowiki> The average age-group for leukemia patients in 2019 is 15.14 (3,867 patients). The age range of patients diagnosed with Lymphocytic Chronic B-Cell leukemia was 12.97 to 21.23 (2,849 patients)<nowiki>.</nowiki> The mean age of men diagnosed with lymphocytic chronic B-cell leukemia was 16.7 and women diagnosed with lymphocytic chronic B-cell leukemia was 17.47." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cyclophosphamide?

"Common side effects are reported during treatment with cyclophosphamide with the frequency of occurrence below 20% (NCT00367961). Moreover, most frequently reported side effects are infusion-related symptoms which are reversible after infusion discontinuation. Nevertheless, a complete blood count should be done to monitor the blood cell counts at baseline and during treatment with cyclophosphamide." - Anonymous Online Contributor

Unverified Answer

Does cyclophosphamide improve quality of life for those with leukemia, lymphocytic, chronic, b-cell?

"Patients receiving CSA have similar overall health-related quality of life when compared with those receiving CC for a year, and this result was not adversely related to the higher incidence of infections and lower survival observed in this cohort (P = 0.5989). Findings from a recent study indicates that CSA has no clinically significant impact on patient quality of life in general and is not recommended for treatment of [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia), chronic neutropenic leukemia, or CLL with concomitant myelosuppression." - Anonymous Online Contributor

Unverified Answer

Is cyclophosphamide typically used in combination with any other treatments?

"The use of A + cyclophosphamide-A + TSH was frequently reported; however, data to support the efficacy of this approach was typically limited. [Power (http://www.withpower.com/clinical-trials/cancer/cyclophosphamide)) Cyclophosphamide is typically used in combination with other treatments, but there was no evidence available to support the use of it alone. Please see Power to find evidence (references below) related to therapy. Cytostatics such as cyclophosphamide are typically used in patients who (a) have undergone hematopoietic stem cell transplantation and (b) develop progressive disease that has failed other treatment strategies." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for leukemia, lymphocytic, chronic, b-cell?

"The survival rate for leukemia, lymphocytic, chronic, b-cell at 10 to 11 years of age with TPAB is 20%. The 5-year survival rate is 8%; and the overall survivals are 13%. Thus, leukemia, lymphocytic, chronic, b-cell is a serious disease in children with TPAB." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in cyclophosphamide for therapeutic use?

"A combination of cyclophosphamide and low-dose doxorubicin, an antimicrotubule agent in combination with calcineurin inhibitors, is associated with high rates of complete remission. Cyclophosphamide is now more widely used after the development of anthracycline-containing regimens and is being used to treat other neoplasms as well as acute leukemia. In addition, this combination was found to be very well tolerated in a prospective randomized trial of patients with chronic lymphocytic leukemia. This combination is recommended for further investigation to ascertain its usefulness as an induction regimen and for patients unfit for standard induction regimens." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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