NCT00248547 · REGISTRY CONDITION SEARCH

Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2017-05-09

RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant. PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Emesis Free Participants During the Study Period.

→

outcome · NOT POSTED

Safety in Transplant Population

→

outcome · NOT POSTED

Effects on Nausea, Appetite and Taste Changes

→

outcome · NOT POSTED

Pharmacokinetic Interaction

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion: * 18 years of age or greater * must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell transplant * Eastern Cooperative Oncology Group(ECOG) performance status \< or = 2 * patients must have signed informed consent * must be able to swallow tablets and capsules * must be receiving a cyclophosphamide containing regimen. Exclusion: * patient has known sensitivity to aprepitant, ondansetron, or dexamethasone * patient has received another investigational drug in the past 30 days * patient has had emesis or requires antiemetic agents in the 48 hours prior to beginning conditioning therapy * patient has taken neurokinin-1 antagonists for 14 days prior to enrollment * patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is lactating * patient has serum creatinine level \> or = 2\*ULN * patient has severe hepatic insufficiency (Child-Pugh score \>9) * patient drinks \> 5 drinks/day for the last year * patient with concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: aprepitant
Drug: dexamethasone
Drug: ondansetron
label
Aprepitant
type
ACTIVE_COMPARATOR
description
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
intervention Names
Drug: dexamethasone
Drug: ondansetron
Drug: placebo
label
sugar pill
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Aprepitant
description
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
name
aprepitant
other Names
Emend
type
DRUG
arm Group Labels
Aprepitant
sugar pill
description
For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.
name
dexamethasone
other Names
Decadron
type
DRUG
arm Group Labels
Aprepitant
sugar pill
description
For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy
name
ondansetron
other Names
Zofran
type
DRUG
arm Group Labels
sugar pill
description
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
name
placebo
other Names
placebo, sugar pill
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 40
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period
measure
Number of Emesis Free Participants During the Study Period.
time Frame
Up to three weeks

secondary Outcomes

description
To assess the safety of aprepitant in the bone marrow transplant population
measure
Safety in Transplant Population
time Frame
Up to three weeks
description
To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale \[VAS\]), nutritional intake, and mucositis in the bone marrow transplant population.
measure
Effects on Nausea, Appetite and Taste Changes
time Frame
Up to three weeks
description
To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.
measure
Pharmacokinetic Interaction
time Frame
Up to three weeks

Full study description

brief Summary: RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant. PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.
detailed Description: OBJECTIVES: Primary * Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting, as determined by the number of retch/emesis-free days, in patients undergoing hematopoietic stem cell transplantation. Secondary * Determine the safety of aprepitant in these patients. * Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients treated with these regimens. * Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard, hydroxycyclophylamide, and aprepitant in these patients. OUTLINE: This is a randomized, placebo-controlled, single-blind, pilot study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Beginning on the first day of conditioning chemotherapy, patients receive oral aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron and oral dexamethasone. * Arm II: Patients receive oral placebo once daily and standard antiemetic therapy as in arm I. In both arms, treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity. After completion of study therapy, patients are followed until day 18. PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-200347137387c0de8d1d
requested nct id
NCT00248547
primary nct id
NCT00248547
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
payload sha256
3e68863dba8abfcf5fab6449c517c1c64b403e12233bab1cce0c7ec3f8795dba
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-200347137387c0de8d1d
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00248547
occurrences
context exact
NCT00248547
end
11
exact text
NCT00248547
start
0
offset unit
unicode_code_points
query cond
Juvenile Myelomonocytic Leukemia
query disease state id
ds-juvenile-myelomonocytic-leukemia
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
source json pointer
/studies/83/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d41008fe6efa51ce44a6d00da2c60ca3bae167c0fb557817dea860f97496cbaa
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-26896a8700d534483b3f
requested nct id
NCT00248547
primary nct id
NCT00248547
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Hairy+Cell+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
payload sha256
e9d108f6a40fa395021aed8a2295355cf1e42943289e6a6fa20da89f8c5d75cd
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-26896a8700d534483b3f
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00248547
occurrences
context exact
NCT00248547
end
11
exact text
NCT00248547
start
0
offset unit
unicode_code_points
query cond
Hairy Cell Leukemia
query disease state id
ds-hairy-cell-leukemia
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hairy-cell-leukemia-000.json
source file sha256
8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
source json pointer
/studies/28/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d41008fe6efa51ce44a6d00da2c60ca3bae167c0fb557817dea860f97496cbaa
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Hairy+Cell+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-4bf21f3c3342cc07ea1a
requested nct id
NCT00248547
primary nct id
NCT00248547
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Gestational+Trophoblastic+Disease&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
1f1a29f1a432464f61f3af08097eaeb6242ebe2e1ee6ac5865a817223b28632a
payload sha256
e194d1eb79775c09e0d35a0dcc7ed9d3f48e3f60a55d5fcf68f97326543887f4
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-4bf21f3c3342cc07ea1a
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00248547
occurrences
context exact
NCT00248547
end
11
exact text
NCT00248547
start
0
offset unit
unicode_code_points
query cond
Gestational Trophoblastic Disease
query disease state id
ds-gestational-trophoblastic-disease
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-gestational-trophoblastic-disease-000.json
source file sha256
1f1a29f1a432464f61f3af08097eaeb6242ebe2e1ee6ac5865a817223b28632a
source json pointer
/studies/4/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d41008fe6efa51ce44a6d00da2c60ca3bae167c0fb557817dea860f97496cbaa
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Gestational+Trophoblastic+Disease&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-94d6ec59a81f0c1f8776
requested nct id
NCT00248547
primary nct id
NCT00248547
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
c54c6bdc7c0592a1929bce4f33bb39431b16dfe1c567bf65ed37abb332813fda
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-94d6ec59a81f0c1f8776
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00248547
occurrences
context exact
NCT00248547
end
11
exact text
NCT00248547
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/595/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d41008fe6efa51ce44a6d00da2c60ca3bae167c0fb557817dea860f97496cbaa
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-b2232974aedf5323c7ad
requested nct id
NCT00248547
primary nct id
NCT00248547
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Peripheral+T-Cell+Non-Hodgkin+Lymphoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
payload sha256
aa776d6520d27a51f796c1d71d4a38e94cc7ac3c9d4ead7bed5c5c6565ba27ce
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-b2232974aedf5323c7ad
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00248547
occurrences
context exact
NCT00248547
end
11
exact text
NCT00248547
start
0
offset unit
unicode_code_points
query cond
Peripheral T-Cell Non-Hodgkin Lymphoma
query disease state id
ds-peripheral-t-cell-non-hodgkin-lymphoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
source file sha256
e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
source json pointer
/studies/74/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d41008fe6efa51ce44a6d00da2c60ca3bae167c0fb557817dea860f97496cbaa
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Peripheral+T-Cell+Non-Hodgkin+Lymphoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-bd66dcb2da4f40e399b9
requested nct id
NCT00248547
primary nct id
NCT00248547
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Testicular+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
payload sha256
661abb8b49a510a939e155c732fd9b3ac6d54f77ece159e843467e839ce2a6d9
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-bd66dcb2da4f40e399b9
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00248547
occurrences
context exact
NCT00248547
end
11
exact text
NCT00248547
start
0
offset unit
unicode_code_points
query cond
Testicular Cancer
query disease state id
ds-testicular-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
source file sha256
9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
source json pointer
/studies/28/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d41008fe6efa51ce44a6d00da2c60ca3bae167c0fb557817dea860f97496cbaa
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Testicular+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-ced2058483682a3a348b
requested nct id
NCT00248547
primary nct id
NCT00248547
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Ovarian+Germ+Cell+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
payload sha256
13beea67db5cda1e60a874147c34248a85d53f9415db65db223588331f5c806b
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-ced2058483682a3a348b
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00248547
occurrences
context exact
NCT00248547
end
11
exact text
NCT00248547
start
0
offset unit
unicode_code_points
query cond
Ovarian Germ Cell Tumors
query disease state id
ds-ovarian-germ-cell-tumors
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-ovarian-germ-cell-tumors-000.json
source file sha256
359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
source json pointer
/studies/46/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d41008fe6efa51ce44a6d00da2c60ca3bae167c0fb557817dea860f97496cbaa
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Ovarian+Germ+Cell+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice