NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Pilot Prospective Study for PET-CT Imaging in Participants with Relapsed/Refractory Acute Leukemias

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001620-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5 Years
Max Age: 39 Years

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Neonates;
Pregnant Women

Keywords

Imaging;
Natural History;
ACUTE LEUKEMIA

Recruitment Keyword(s)

None

Condition(s)

B Cell;
Acute Lymphoblastic Leukemia;
Relapsed/Refractory

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background

Acute lymphoblastic leukemia (ALL) accounts for about 25% of childhood cancers and for about 20% of adult leukemias. The disease can be treated with CAR T-cell infusion but non-central nervous system (CNS) extramedullary disease (EMD) is associated with lower rates of complete remission. 18-fludeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) has been shown to be effective for detection of non-CNS EMD in ALL. Pre and post CAR T-cell infusion may help to predict outcomes and risk of early progression.

Objectives

To describe the number of adults with relapsed/refractory B-cell ALL who proceed to CAR T-cell therapy.

Eligibility

Participants >=18 years with relapsed/refractory B-cell ALL who are being screened for CAR T-cell clinical trial enrollment, and

Participants <18 with relapsed/refractory B cell ALL who are being screened for CAR T-cell clinical trial enrollment and have a clinical indication for FDG PET-CT prior to CAR infusion.

Design

Pilot study to add screening FDG PET-CT as part of the pre-CAR T-cell baseline evaluation with additional imaging at day 28 and future timepoints pending evidence of non-CNS EMD on initial scan.

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Eligibility

INCLUSION CRITERIA:

-Diagnosis: Participants must have a B cell ALL (inclusive of CML with ALL transformation)

-Age: 5-39 years

--All participants >=18 years old with relapsed/refractory B cell ALL potentially proceeding to CAR therapy at the NIH, or

--Any participant <18 potentially proceeding to CAR therapy at the NIH with a clinical indication for FDG PET-CT prior to CAR infusion:

---History of prior EMD

---History of post-HSCT relapse

---Clinical signs or incidental findings suspicious for EMD

---Peripheral disease out of proportion of bone marrow disease burden

-Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding within 24 hours of any PET-CT scan

-Ability and willingness of participant or Legally Authorized Representative (LAR) to coenroll on protocol 10-C-0086 "Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies".

-Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

-Pregnant women are excluded from this study

-History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study (e.g., FDG injection)


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Nirali N. Shah, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-5750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6970
shahnn@mail.nih.gov

NCI Pediatric Leukemia, Lymphoma Transpl
National Cancer Institute (NCI)

(240) 760-6970
ncilltct@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT05969002

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Pilot Prospective Study for PET-CT Imaging in Participants with Relapsed/Refractory Acute Leukemias

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001620-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5 Years
Max Age: 39 Years

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Neonates;
Pregnant Women

Keywords

Imaging;
Natural History;
ACUTE LEUKEMIA

Recruitment Keyword(s)

None

Condition(s)

B Cell;
Acute Lymphoblastic Leukemia;
Relapsed/Refractory

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background

Acute lymphoblastic leukemia (ALL) accounts for about 25% of childhood cancers and for about 20% of adult leukemias. The disease can be treated with CAR T-cell infusion but non-central nervous system (CNS) extramedullary disease (EMD) is associated with lower rates of complete remission. 18-fludeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) has been shown to be effective for detection of non-CNS EMD in ALL. Pre and post CAR T-cell infusion may help to predict outcomes and risk of early progression.

Objectives

To describe the number of adults with relapsed/refractory B-cell ALL who proceed to CAR T-cell therapy.

Eligibility

Participants >=18 years with relapsed/refractory B-cell ALL who are being screened for CAR T-cell clinical trial enrollment, and

Participants <18 with relapsed/refractory B cell ALL who are being screened for CAR T-cell clinical trial enrollment and have a clinical indication for FDG PET-CT prior to CAR infusion.

Design

Pilot study to add screening FDG PET-CT as part of the pre-CAR T-cell baseline evaluation with additional imaging at day 28 and future timepoints pending evidence of non-CNS EMD on initial scan.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

-Diagnosis: Participants must have a B cell ALL (inclusive of CML with ALL transformation)

-Age: 5-39 years

--All participants >=18 years old with relapsed/refractory B cell ALL potentially proceeding to CAR therapy at the NIH, or

--Any participant <18 potentially proceeding to CAR therapy at the NIH with a clinical indication for FDG PET-CT prior to CAR infusion:

---History of prior EMD

---History of post-HSCT relapse

---Clinical signs or incidental findings suspicious for EMD

---Peripheral disease out of proportion of bone marrow disease burden

-Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding within 24 hours of any PET-CT scan

-Ability and willingness of participant or Legally Authorized Representative (LAR) to coenroll on protocol 10-C-0086 "Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies".

-Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

-Pregnant women are excluded from this study

-History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study (e.g., FDG injection)


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Nirali N. Shah, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-5750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6970
shahnn@mail.nih.gov

NCI Pediatric Leukemia, Lymphoma Transpl
National Cancer Institute (NCI)

(240) 760-6970
ncilltct@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT05969002

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