CLINICAL TRIAL

Fludarabine for Residual Tumor

Recruiting · Any Age · All Sexes · Seattle, WA

This study is evaluating whether a type of white blood cell can be used to treat leukemia.

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About the trial for Residual Tumor

Eligible Conditions
Leukemia, Biphenotypic, Acute · Syndrome · Leukemia, Myeloid, Acute · Blast Crisis · Leukemia, Myelomonocytic, Chronic · Leukemia, Myeloid · Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Refractory Acute Lymphoblastic Leukemia (ALL) · Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Myelodysplastic Syndromes (MDS) · Acute Myeloid Leukemia (AML) · Recurrent Acute Biphenotypic Leukemia · acute, recurrent Undifferentiated Leukemia · Acute Lymphoblastic Leukemia (ALL) · Leukemia Chronic Myelogenous Leukemia (CML) · Leukemia, Lymphoid · Juvenile Myelomonocytic Leukaemias (JMML) · Recurrent Childhood Acute Lymphoblastic Leukemia · Acute Undifferentiated Leukemia (AUL) · Neoplasms · Preleukemia · Leukemia, Myelomonocytic, Juvenile · Mixed Phenotype Acute Leukemia (MPAL) · Recurrent Acute Lymphoblastic Leukemia · Acute Biphenotypic Leukemia (ABL) · Precursor Cell Lymphoblastic Leukemia-Lymphoma · Chronic Myelomonocytic Leukemia (CMML) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Myelodysplastic Syndromes · Acute Disease · Recurrent Childhood Acute Myeloid Leukemia · Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Refractory Adult Acute Lymphoblastic Leukemia · Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm · acute, recurrent Myeloid Leukemia · Recurrent Mixed Phenotype Acute Leukemia · Leukemia · Refractory Myelodysplastic Syndromes · Minimal Residual Disease · Leukemia, Myelomonocytic, Acute · Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm · Recurrent Myelodysplastic Syndrome · chronic, recurrent Myelomonocytic Leukemia · Neoplasm, Residual

Treatment Groups

This trial involves 2 different treatments. Fludarabine 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR
BIOLOGICAL
Fludarabine
DRUG
Laboratory Biomarker Analysis
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Residual Tumor or one of the other 43 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Mixed phenotype leukemia is a type of leukemia characterized by the presence of both myeloid and lymphoid cells show original
, most centers would discontinue sFLCs because of the high risk of Richter transformation If someone has a relapse or refractory disease (blast cells present in their bone marrow or circulating in their blood at a level of 5% or higher) at any time after receiving a hematopoietic cell transplant (HCT), most centers would discontinue serum free light chains (sFLCs) because of the high risk of Richter transformation. show original
Patients must have the HA-1(H) genotype (RS_1801284: A/G, A/A)
Patients who are 16 years or older will initially receive HA-1-TCR T cell infusions on the protocol show original
Myelodysplastic syndrome (MDS) of any subtype
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Fludarabine will improve 3 primary outcomes and 9 secondary outcomes in patients with Residual Tumor. Measurement will happen over the course of At the time of T cell infusion (at day 0).

Specific cytolytic activity of HA-1 T cell receptor (TCR) CD8+ and CD4+ T cells against HLA-A*0201+ HA-1+ target cells before adoptive T cell transfer
AT THE TIME OF T CELL INFUSION (AT DAY 0)
Assessed by in vitro chromium release assay or equivalent cytotoxicity assay.
Feasibility of manufacturing minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells
AT TIME OF T CELL INFUSION (AT DAY 0)
Proportion of participants for whom a HA-1 TCR T cell product can be produced.
Feasibility of administering minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells
AT TIME OF T CELL INFUSION (AT DAY 0)
Proportion of participants for whom a HA-1 TCR T cell product can be administered.
Incidence of dose-limiting toxicities of HA-1 T cell receptor (TCR) T cells
UP TO 12 WEEKS AFTER T-CELL INFUSION
Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Presence, proportion and persistence of HA-1 T cell receptor (TCR) CD8+ T cells in the bone marrow
UP TO 1 YEAR
Evaluated by tetramer and/or molecular tracking e.g. qPCR.
Duration of in vivo persistence of transferred HA-1 T cell receptor (TCR) CD4+ T cells in peripheral blood
UP TO 1 YEAR
Evaluated by tetramer and/or molecular tracking e.g. quantitative polymerase chain reaction (qPCR).
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Patient Q & A Section

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

What are common treatments for residual tumor?

There is no consensus for the evaluation of residual tumor following curative treatments of patients with prostate cancer. Different evaluation modes could be included into protocols.

Anonymous Patient Answer

What is residual tumor?

Removing the residual tumor with the assistance of stereotactic radiosurgery appears to be associated with significantly better patient survival compared to patients who were treated with post-operative whole brain irradiation and chemotherapy; whereas patients who were treated with only post-operative whole brain irradiation and chemotherapy or with post-operative whole brain irradiation alone had no survival advantage over those not treated with a residual tumor surgery.

Anonymous Patient Answer

What are the signs of residual tumor?

The signs of a residual tumor include the presence of a palpable abnormality or a mass. These signs typically involve the soft tissues and the lymph nodes surrounding the joint.

Anonymous Patient Answer

Can residual tumor be cured?

As most patients with localized recurrence do not have residual tumors, there is a high likelihood of cure in this group of patients. However, the group is a heterogeneous group--in this study, 23.5% of patients had residual tumors, and most of them could not be cured from these residual tumors.

Anonymous Patient Answer

How many people get residual tumor a year in the United States?

A very small number of patients who have complete surgical excision of the tumor have persistent tumor. In the United States, an estimated 40,000 patients develop tumor out of their entire resection specimen.

Anonymous Patient Answer

What causes residual tumor?

Patients' age and the type of tumor resection may be prognostic factors for the residual tumor. The most effective treatment strategy in patients with residual tumors may be determined by the type of tumor reseced during surgery.

Anonymous Patient Answer

How does fludarabine work?

Residual tumor mass is a critical factor in determining the chance of long-term remission, and is the first predictive factor for relapse-free survival, although most patients experience a significant decline in their cancer-related quality of life.

Anonymous Patient Answer

What are the latest developments in fludarabine for therapeutic use?

fludarabine is an effective chemotherapy to reduce the residual tumor burden in patients with high-risk hairy cell leukemia. The most frequent adverse effects, such as vomiting, neutropenia, and anemia, were dose-related phenomena associated with the administration of fludarabine. The authors also discuss the potential for improving the pharmacokinetics of fludarabine.

Anonymous Patient Answer

What is the survival rate for residual tumor?

There are four potential factors that can affect long-term survival rates of patients with residual tumor; the extent to which residual tumor affects patients' lifestyle, the surgical completeness, the pre-operative tumor volume, and the post-operative therapy. The extent to which residual tumor affects patients' lifestyle and the surgical completeness have an independent effect on survival outcomes. When patients present to the clinic with residual tumor, the survival rate should be carefully considered and a thorough assessment should be done to the best treatment plan for residual tumor.

Anonymous Patient Answer

What are the common side effects of fludarabine?

Patients undergoing CHOP or other HDAC inhibitor therapy may experience hypersensitivity reactions, skin reactions, nausea, vomiting, or anemia. The timing and frequency of side effects appear to be more important variables than the dosage used.

Anonymous Patient Answer

How quickly does residual tumor spread?

In a recent study, findings of this study have identified a time course of development of residual tumor as soon as 24 h after irradiation. To assess whether residual tumor cells are still present, or whether further treatment is warranted, biopsies are needed at specific time intervals.

Anonymous Patient Answer

How serious can residual tumor be?

Residual tumor was common among patients with advanced-stage ovarian cancer. The percentage of residual tumors did not correlate with the type of chemotherapy, the grade of tumors or the number of chemotherapies. Patients with residual tumor may benefit of adjuvant chemotherapy, which may be a crucial method to improvement survival for advanced-stage ovarian cancer.

Anonymous Patient Answer
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